System and method for hearing screening on a listening device

Abstract

A system (100) includes a listening device (105) with a processor (110), memory (112), speaker driver (120), and microphone (130) for determining hearing loss. The memory includes processor-executed instructions (155) for carrying out steps including transmitting an ultrasound tone to a user of the listening device (105); measuring length of an ear canal of the user after receiving a reflected ultrasound signal; transmitting an audible sound to the user of the listening device; transmitting an ultrasound tone to the user of the listening device (105) and measuring length of an ear canal of the user after receiving a reflected ultrasound signal; comparing the measurement of the length of the ear canal before and after the audible sound transmission; and if there is no change or minimal change in the length, notifying the user of hearing loss or controlling the listening device to limit sound level.

Description

Docket No. 2024PF00216- PATENT -SYSTEM AND METHOD FOR HEARING SCREENING ON A LISTENING DEVICEFIELD OF THE INVENTION

[0001] The invention relates to the field of audiology, and more specifically to screening for hearing loss.BACKGROUND OF THE INVENTION

[0002] In past years, active noise cancelling (ANC) headphones have a taken a significant share of the consumer headphones market. The suppression of environmental noise by ANC offers various benefits like more undisturbed enjoyment of music and more intelligible communications for phone calls or for audio or video teleconferencing. An example of an over-the-ear headphone with ANC is shown in Fig. 1 A. In more recent years, the ANC technology has also been brought to in-ear headphones, also commonly referred to as earbuds. One very popular and widespread example is the Apple® AirPods Pro® earbuds (Fig. IB).

[0003] With an increasing portion of consumers using headphones, being also enabled to listen to music at elevated loudness levels without disturbing others, there is a widespread concern of hearing loss in the general population. Beyond making consumers aware of the risks, products like Apple® iPhone® try to keep track of the user’s cumulative exposure to loud sound and to warn the user if certain thresholds are exceeded. More information about auditory physiology and hearing loss in connection with warnings and limiting sound pressure levels is described in Published U.S. Patent Application US 2023247344 Al to David Patrick Warner (hereinafter “Warner ‘344”). Warner ‘344 describes automatically and dynamically controlling the output (e.g., volume) of an audio headphone device, which includes detecting the invocation of the acoustic reflex with an audio headphone device in between songs or music playing, such that warnings can be provided or sound pressure levels can be reduced. While such preventive measures are useful, they do not resolve the need for early detection or screening of actual hearing loss in a human being. Warner ‘344 only determines whether the acoustic reflex is triggered and fails to measure characteristics of ear physiology or identify damage to ear physiology indicativeDocket No. 2024PF00216- PATENT - of hearing loss.

[0004] In general, measuring the acoustic reflex of the ear, also known by various other names e.g. stapedial reflex or tympanic reflex, is well known and also discussed in Warner ‘344. See https: / / en.wikipedia.org / wiki / Acoustic_reflex / . Acoustic reflex serves to acoustically decouple various elements in the middle ear in response to loud sounds, so as to reduce the sound level inside the ear and thus protect the ear from damage. A reduction or absence of acoustic reflex is an indication of hearing loss, which can be either temporal (e.g., due to an infection inside the ear) or of more permanent nature (e.g., due to persistent injury caused by exposure to loud sound). If the reflex is over-sensitive i.e. occurring even for soft sounds, this can point to hyperacusis.

[0005] The common measurement of the acoustic reflex is via tympanometry, where the air pressure in the ear canal is raised by external pressure, and the compliance of the tympanic membrane (including its stiffness due to the reflex being activated) is subsequently measured using e.g. audible tones. Another less often used way is to measure the tympanic membrane’s compliance by laser, where the acoustic reflex is activated by loud sounds like tone bursts or gunshot noise. Tympanometers for measuring acoustic reflex are sold for example by Interacoustics and used in clinical setting to test hearing. However, in today’s practice, to measure the acoustic reflex is a convolved operation. It requires costly custom equipment, such as tympanometers, that must be operated by a trained professional or caregiver, and a strict protocol must be followed. Otherwise, the operation of the equipment will result in inaccurate readings. Also, the procedure (often including an air pressure increase) can be perceived as stressful or unpleasant to the patient.

[0006] Additionally, some headphones or earbuds have capability to measure the oto-acoustic emission (OAE) phenomenon, as published in the article, Justin Chan et al. An off-the-shelf otoacoustic-emission probe for hearing screening via a smartphone, Nature Biomedical Engineering, volume 6, pages 1203-1213 (2022). The human ear emits (very low-level) sound on itself, especially in response to a stimulus such as a sine tone. This is due to hairs inside the inner ear that continue to vibrate briefly after the vibration stimulus (i.e., sound) is removed. If the OAE response sound is not present, then this is an indication of hearing loss in general, and further examination may be opportune. However, OAE lacks specificity and there is a risk of false positives due to contamination from other sounds, either from the test environment or internal sounds such as breathing and swallowing. Richardson MP, Williamson TJ, Lenton SW, TarlowDocket No. 2024PF00216- PATENT -MJ, Rudd PT. Otoacoustic emissions as a screening test for hearing impairment in children. Arch Dis Child. 1995 Apr;72(4):294-7. During analysis, it may also be challenging to distinguish OAE from background noise. Thus, most OAE requires analysis of the reproducible data and the signal- to-noise ratio of the OAE waveform. Since OAE travel through the middle ear, they can also be affected by any middle ear disease, such as middle ear effusion.

[0007] Thus, there is a need for accurate screening for hearing problems such that intervention by professionals is not required for screening, and hence, early detection is possible even before the consumer has any (conscious) complaints or concerns. The present application proposes an innovative technical solution that addresses the present need and is handled by headphones or earbuds, as described more fully below.SUMMARY OF THE INVENTION

[0008] According to a representative embodiment, a method is provided for determining hearing loss with a listening device, wherein the method comprises the processor-executed steps of: transmitting an ultrasound tone to a user of the listening device; measuring length of an ear canal of the user after receiving a reflected ultrasound signal; transmitting an audible sound to the user of the listening device; transmitting an ultrasound tone to the user of the listening device and measuring length of an ear canal of the user after receiving a reflected ultrasound signal; comparing the measurement of the length of the ear canal before and after the audible sound transmission; and if there is no change or minimal change in the length, notifying the user of hearing loss or controlling the listening device to limit sound level.

[0009] According to another representative embodiment, the listening device is an over-the-ear headphone, on-the-ear headphone, earbuds, or active noise canceling device (ANC).

[0010] According to another representative embodiment, the step of transmitting an ultrasound tone is performed with an ultrasound transducer.

[0011] According to another representative embodiment, the step of transmitting an audible sound is performed with a speaker driver and the processor is configurable to switch between transmitting the ultrasound tone with the ultrasound transducer and transmitting the audible sound with the speaker driver.

[0012] According to another representative embodiment, the method is activated by an electronicDocket No. 2024PF00216- PATENT - device connected to the listening device, wherein the electronic device is a smartphone, smartwatch, health tracker, fitness tracker, a tablet, or a desktop computer

[0013] According to another representative embodiment, the length is expressed as an equivalent length modeling the ear canal based on a pipe.

[0014] According to another representative embodiment, the equivalent length is measured with coherent detection.

[0015] According to another representative embodiment, ambient noise is detected prior to the start of the method and the method is suppressed until ambient noise is no longer present.

[0016] According to another representative embodiment, a non-transitory computer readable medium is provided that stores instructions for determining hearing loss with a listening device, wherein the instructions are executable by a processor to carry out any of the aforementioned steps in representative embodiments.

[0017] According to another representative embodiment, a listening device comprises: means for transmitting an ultrasound tone to a user of the listening device; a processor for measuring length of an ear canal of the user after a reflected ultrasound signal is received; and a speaker for transmitting an audible sound to the user of the listening device; wherein the processor compares the measurement of the length of the ear canal before and after the audible sound transmission, and if there is no change or minimal change in the length, the processor issues a notification to the user of hearing loss or controls the listening device to limit sound level.

[0018] According to another representative embodiment, the listening device is an over-the-ear headphone, on-the-ear headphone, earbuds, or an active noise canceling device (ANC).

[0019] According to another representative embodiment, a system is provided for determining hearing loss, wherein the system includes a listening device with a processor and a memory containing one or more software modules or instructions executable by the processor for transmitting an ultrasound tone to a user of the listening device; measuring length of an ear canal of the user after receiving a reflected ultrasound signal; transmitting an audible sound to the user of the listening device; transmitting an ultrasound tone to the user of the listening device and measuring length of an ear canal of the user after receiving a reflected ultrasound signal; comparing the measurement of the length of the ear canal before and after the audible sound transmission; and if there is no change or minimal change in the length, notifying the user of hearing loss orDocket No. 2024PF00216- PATENT - controlling the listening device to limit sound level.

[0020] According to another representative embodiment, a non-transitory computer readable medium is provided that stores instructions for determining hearing loss with a listening device, wherein the non-transitory computer readable medium contains one or more software modules or instructions executable by a processor for transmitting an ultrasound tone to a user of the listening device; measuring length of an ear canal of the user after receiving a reflected ultrasound signal; transmitting an audible sound to the user of the listening device; transmitting an ultrasound tone to the user of the listening device and measuring length of an ear canal of the user after receiving a reflected ultrasound signal; comparing the measurement of the length of the ear canal before and after the audible sound transmission; and if there is no change or minimal change in the length, notifying the user of hearing loss or controlling the listening device to limit sound level.

[0021] According to another representative embodiment, a non-transitory computer readable medium is provided that stores instructions for determining hearing loss with a listening device, which are executable by a processor to carry out any of the steps or functions described herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0022] The example embodiments are best understood from the following detailed description when read with the accompanying drawing figures. It is emphasized that the various features are not necessarily drawn to scale. In fact, the dimensions may be arbitrarily increased or decreased for clarity of discussion. Wherever applicable and practical, like reference numerals refer to like elements.

[0023] FIG. 1 A is a drawing of an exemplary an over-the-ear headphone with ANC.

[0024] FIG. IB is a drawing of Apple® AirPods Pro® earbuds.

[0025] FIG. 2A is a block diagram of a representative embodiment.

[0026] FIG. 2B is a block diagram of a representative embodiment with a switching circuitry.

[0027] FIG. 3 is a block diagram of a representative embodiment with a microcontroller.

[0028] FIG. 4A is a block diagram of a representative embodiment with transducer.

[0029] FIG. 4B is a block diagram of a representative embodiment with transducer and switching circuitry.

[0030] FIG. 5A is a flow chart of a representative embodiment.Docket No. 2024PF00216- PATENT -

[0031] FIG. 5B is a diagrammatic representation of a listening device measuring the length of an ear canal through the method shown in FIG. 5A.

[0032] FIG. 6 shows a block diagram of a representative embodiment with a switch.

[0033] FIGS. 7A-7D show various representative embodiments including an electronic device.DETAILED DESCRIPTION OF EMBODIMENTS

[0034] Any of the steps described in relation to examples described below can be performed by a processor, computer-readable medium or data carrier system, and processor-executable instructions configured to carry out any of the steps described. The processor performs logical processing based on received analog or digital signals.

[0035] In the following detailed description, for the purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. Descriptions of known systems, devices, materials, methods of operation and methods of manufacture may be omitted so as to avoid obscuring the description of the representative embodiments. Nonetheless, systems, devices, materials and methods that are within the purview of one of ordinary skill in the art are within the scope of the present teachings and may be used in accordance with the representative embodiments. It is to be understood that the terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. The defined terms are in addition to the technical and scientific meanings of the defined terms as commonly understood and accepted in the technical field of the present teachings.

[0036] It will be understood that, although the terms first, second, third, etc. may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are only used to distinguish one element or component from another element or component. Thus, a first element or component discussed below could be termed a second element or component without departing from the teachings of the inventive concept.

[0037] The terminology used herein is for purposes of describing particular embodiments only and is not intended to be limiting. As used in the specification and appended claims, the singular forms of terms “a,” “an” and “the” are intended to include both singular and plural forms, unless the context clearly dictates otherwise. Additionally, the terms “comprises,” “comprising,” and / orDocket No. 2024PF00216- PATENT - similar terms specify the presence of stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0038] Unless otherwise noted, when an element or component is said to be “connected to”, “coupled to”, or “adjacent to” another element or component, it will be understood that the element or component can be directly connected or coupled to the other element or component, or intervening elements or components may be present. That is, these and similar terms encompass cases where one or more intermediate elements or components may be employed to connect two elements or components. However, when an element or component is said to be “directly connected” to another element or component, this encompasses only cases where the two elements or components are connected to each other without any intermediate or intervening elements or components.

[0039] The present disclosure, through one or more of its various aspects, embodiments and / or specific features or sub-components, is thus intended to bring out one or more of the advantages as specifically noted below. For purposes of explanation and not limitation, example embodiments disclosing specific details are set forth in order to provide a thorough understanding of an embodiment according to the present teachings. However, other embodiments consistent with the present disclosure that depart from specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted so as to not obscure the description of the example embodiments. Such methods and apparatuses are within the scope of the present disclosure.

[0040] Generally, the present disclosure is directed to a system and method for performing a measurement of hearing loss of a subject using a listening device such as headphones or earbuds. In at least one embodiment, the headphones are ANC headphones. In other embodiments, the headphones are on-the-ear headphones or over-the-ear headphones or the listening device is earbuds.

[0041] FIG. 2A is a simplified block diagram of a system for performing a measurement of the hearing loss of a subject using a listening device, according to a representative embodiment.

[0042] Referring to FIG. 2A, system 100 includes a listening device 105 capable of reproducingDocket No. 2024PF00216- PATENT - audio or audio playback (e.g., music or audio playback from a connected external device such as an audio player or smartphone), and screening for hearing loss in a subject as described in more detail in method 200 below. Thus, the listening device 105 is operable in an audio playback mode and in hearing loss screening mode. Listening device 105 comprises at least one processor 110 for processing audio playback and generating either an audible sound signal or ultrasound tone signal, a memory 112 for storing information, an amplifier 115 for providing the electrical signal that drives the diaphragm 125 in the speaker driver 120 to produce and transmit sound or ultrasound tones to a user, a power supply (not shown) connected to the components for supplying stable power to the components and circuitry of the listening device 105, a diaphragm 125 for vibrating air to reproduce sound, and a microphone 130 for receiving reflected ultrasound signals, user speech for handsfree communication, and voice commands as well as other optional functions to be described in more detail. Memory 112 includes computer executable instructions, that when executed by processor 110, will either facilitate audio playback (audio playback mode) or generate audible sound and ultrasound tones at different times or in different orders through speaker driver 120 based on the method 200 provided below (hearing loss screening mode). In this embodiment, the processor 110, amplifier 115, and speaker driver 120 are collectively the primary hardware architecture for audio playback, ultrasound tone generation, and audible sound generation. Memory 112 includes instructions, executable by processor 110, to suppress audio playback during the performance of method 200 in hearing loss screening mode. It is further noted that if the system is used in both ears simultaneously, the system will contain two sets of listening devices105 (one for each ear), and thus twice the architecture (i.e., each earbud will include the architecture described above, e.g., two processors, two speaker drivers, etc).

[0043] Fig. 2B shows an alternative embodiment with appropriate switching circuitry 140 for switching between an audio playback mode and a hearing loss screening mode. The two separate modes are required based on the description provided below with respect to the method 200. That is, hearing loss screening mode requires silence at certain stages and operates under a set of instructions that are different from normal audio playback. Audio playback would be destructive to the hearing loss screening mode process if they were simultaneously performed. Thus, it is important that audio playback is suppressed in some manner when the hearing loss screening process of method 200 is performed. Two distinct modes provide for separate processing ofDocket No. 2024PF00216- PATENT - distinct computer executable instructions for different operations, as well as efficiencies in processing a limited number of signals as opposed to processing multiple signals at once. Switching circuitry 140 is embodied for example as a physical switch, a switch with a signal receiver (e.g., speech signal receiver for speech or voice commands such as “turn on audio playback” or “turn on hearing loss screening”, or a switch that is activated by a separate electronic device 170 as described in more detail in connection with Figs. 7A-7D). Speech signals and voice commands may be received through microphone 130 and / or one or more optional external microphones. By combining the signals from left and right sides of a listening device via signal processing, it is even possible to get a clearer, beam-focused signal. Additionally, it may be possible through processor-executable instructions to suppress audio playback in other manners, such as suppression of processing audio by processor 110 (or other upstream or downstream processing of audio), when the nature of the audio is recognized, e.g., through audio recognition processing, as music or other audio playback from a connected external device such as an audio player or smartphone.

[0044] The processor 110 is for example a digital signal processor (“DSP”) configured to process audio signals in digital format based on user settings. The processor 110 transmits the processed audio signal to amplifier 115, which strengthens the signal without altering the audio quality. The amplified signal drives the speaker driver 120, which vibrates the diaphragm 125 to create sounds waves that the subject hears. Speaker driver 120 is for example a dynamic driver, a balanced armature driver for better high frequency detail, or hybrid driver combining dynamic and balanced armature drivers for providing enhanced quality sound across all frequencies. The amplifier 115 is for example embodied as a high-frequency amplifier having a wide bandwidth and low distortion at ultrasonic frequencies. Standard audio amplifiers may not suffice above 20 kHz. Amplifier 115 is for example a Class D Amplifier which is a class of efficient amplifiers capable of handling high frequencies preferred for battery-powered devices such as listening device 105. Microphone 130 is for example capable of detecting ultrasonic frequencies (e.g., piezoelectric, Micro-Electro- Mechanical Systems also known as MEMS) because ultrasound tones typically start at above 20 kHz; to detect ultrasound tones, the microphone 130 should have a frequency response that extends into this range (e.g., 20-100 kHz). MEMS are small, modern microphones used in compact devices. Some high-quality condenser microphones can detect frequencies slightly above 20 kHz.Docket No. 2024PF00216- PATENT -

[0045] The processor 110 is also configured to generate an ultrasound tone for transmission into the ear of the subject, which is amplified by amplifier 115, and transmitted to the speaker driver 120 to produce ultrasound tones. In order to generate the ultrasound tone, the DSP generates a digital signal representing the ultrasonic frequency. For example, to generate a 25 kHz tone, the DSP creates a sine wave or other waveform at that frequency. Optionally, the DSP may also adjust the signal, such as by modulating it, applying filters, or shaping it to match the requirements of the amplifier 115 and speaker driver 120.

[0046] As shown in Fig. 3, listening device 105 may also optionally include a microcontroller 145 configured for control logic and system management such a button inputs, touch controls, LED behavior (e.g., battery status indicator), and / or overseeing communication between DSP and other features such as for example Bluetooth or other wireless functionality. Microcontroller 145 is for example, an ARM Cortex-M series, STM32, or Espressif Systems ESP32 which combines microcontroller functionality with wireless communication.

[0047] In an alternative embodiment, the microcontroller 145 is configured to generate the ultrasound tone in place of the DSP. The microcontroller 145 tunes the switching frequency of pulse- width modulation to generate different waveforms, including ultrasound tones. For example, microcontroller 145 uses PWM to create a signal approximating the desired waveform (e.g., a sine wave at 25 kHz). Such use of PWM can be advantageous to control analog devices such as speaker drivers, without requiring a dedicated Digital-to- Analog converter. The signal generated by the microcontroller 145 is then sent to the amplifier 115 and speaker driver 120 for further processing as previously described. Optionally, the signal generated by the microcontroller 145 is sent to a low-pass filter to smooth it into a clean analog signal before being sent to the amplifier 115 and speaker driver 120. Previously mentioned examples of microcontroller 145 (e.g., ARM Cortex-M series, STM32, or Espressif Systems ESP32) are suitable for this function as well since they have PWM capabilities. Thus, in this embodiment, in accordance with computer-executable instructions for example, the DSP (processor 110) generates the audible sound in a first path to the amplifier 115 and the microcontroller 145 generates the ultrasound tone in a second path to the amplifier 115 at different times through appropriate architecture and in accordance with the method 200 described below.

[0048] While several different embodiments have been shown for a listening device 105 capableDocket No. 2024PF00216- PATENT - of generating ultrasound tones, including a DSP or a microcontroller 145, it is further possible that the ultrasound tone is created by a standalone signal generator that is embodied by way of example, as a dedicated signal generator integrated circuit (IC) or an oscillator circuit embodied as a high- frequency oscillator (e.g., based on crystal or phase-locked loop (PLL) to generate stable ultrasonic frequencies. In such embodiment, the DSP, as processor 110, would continue to play the traditional role of generating audible sound or audio signals.

[0049] While the processor 110 has been exemplified as a digital signal processor in Figs. 2A-2B, it may also be a single chip that integrates both DSP and microcontroller functionalities, irrespective of whether the DSP or microcontroller generates the ultrasound tones. That is, processor 110 is for example embodied as a System-on-Chip (SoC) combining DSP cores and microcontroller cores within a single chip, reducing size and power consumption, and ideal architecture for listening device 105 embodied as small earbuds for example. In this embodiment, a single chip will carry out the assigned functions of the DSP and microcontroller consistent with the above descriptions.

[0050] In one exemplary embodiment, the listening device 105 is an earbud, shaped in a form similar to that shown in Fig. IB, and includes the architecture in Fig. 2A or 2B, or the processor 110 architecture is alternatively a System-on-Chip (SoC) combining DSP cores and microcontroller cores within a single chip.

[0051] In one exemplary embodiment shown in Fig. 4A, listening device 105 alternatively includes a dedicated ultrasound transducer 150 for emitting or transmitting ultrasound tones in place of the speaker driver 120. Ultrasound transducer 150 is for example a piezoelectric transducer. Ultrasound transducers are specifically designed for higher frequencies (above 20 kHz) and are sometimes more efficient for generating ultrasound tones than for example some speaker drivers. However, for the sake of clarity, speaker drivers in general are capable of producing sound waves at ultrasonic frequencies given appropriate amplification and noise filtering. While not necessarily required for earbuds, an ultrasound transducer can be smaller and more energy efficient when operating at ultrasonic frequencies. Listening device 105 is configurable and operable to provide both audible sounds and ultrasound tones. Memory 112 includes computer executable instructions, that when executed by processor 110, will generate audible sound and ultrasound tones at different times or in different orders through speaker driver 120 and ultrasound transducerDocket No. 2024PF00216- PATENT -150 respectively based on the method 200 provided below. As shown in an alternative embodiment in Fig. 4B, the switching circuitry 140 allows the listening device 105 to switch between an audio playback mode and a hearing loss screening mode. Switching circuitry 140 includes by way of example a traditional physical switch 160 for selecting between the two modes of operation. In accordance with computer-executable instructions for example, the DSP (processor 110) generates the audible sound in a first path to the amplifier 115 and the dedicated ultrasound transducer 150 generates the ultrasound tone in a second path at different times through appropriate architecture and in accordance with the method 200 described below. In this embodiment, the processor 110, amplifier 115, and speaker driver 120 are collectively the primary hardware architecture for audible sound generation and the processor 110 and transducer 150 are collectively the primary hardware architecture for ultrasound tone generation.

[0052] For any of the embodiments described above, the listening device 105 optionally includes filter circuitry for cleaning the ultrasonic signal of unwanted noise or lower frequency harmonics. For example, a high-pass filter may be used to remove any low-frequency components to ensure only ultrasonic signals are transmitted. If the signal is generated digitally, an anti-aliasing filter can be used to prevent anti-aliasing artifacts in the output for ensuring a clean signal output.

[0053] Fig. 5 A shows a method 200 for hearing loss screening in a subject using the listening device 105 of the present disclosure. Such measurement is made based on human auditory physiology as shown in Fig 5B. An explanation of the relevant physiology will assist one having ordinary skill in the art to understand the method 200. The acoustic reflex, which is triggered by loud sounds, causes the stapedius and tensor tympani muscles to contract, effectively stiffening the tympanic membrane (eardrum), resulting in a stiffer middle ear system, and thus reducing the intensity of sound reaching the inner ear and protecting it from damage; this is considered a protective mechanism. With an understanding of the relevant ear canal physiology, the present disclosure is directed to measuring a change or variation in length of the ear canal. One example provided in more detail below includes measuring an “equivalent length” of the ear canal. With reference to Fig. 5 A, the measurement of the acoustic reflex applies the principle that the ear canal can be modelled as a half-closed transmission “pipe” with a reflective end “plate” representing the side of the tympanic membrane (ear drum). The tympanic membrane is not rigid but instead complying (vibrating more or less based on stiffening) to some extent with sound waves (andDocket No. 2024PF00216- PATENT - passing the waves into the inner ear to be perceived by the person). However, this soft-ended pipe can still be physically modelled as a half-closed pipe with an equivalent length that depends on the stiffness and compliance of the tympanic membrane, and hence on whether the acoustic reflex has set in or not. The “pipe” will typically appear shorter for a stiff tympanic membrane (loud sound) than for a soft tympanic membrane at rest (no sound).

[0054] Turning now to an application of the above-described listening device 105, listening device 105 is used to measure the hearing loss of a subject in the following manner. The measurement employs an audible or relatively loud sound stimulus such as tone bursts or gun shot to activate the reflex. Since the reflex will stiffen the tympanic membrane, the equivalent length of the ear canal will vary slightly by the reflex. This variation in equivalent length can be measured by subsequent ultrasound probe tones, as will be described in more detail below in connection with Fig. 5 A and method 200. The method 200 operates based on one or more modules 155 of a system 100 or program stored in memory 112 (e.g., on a non-transitory computer readable medium) with instructions that when executed by processor 110 (or similar processing architecture), carry out the steps of the method 200. The term “module” simply refers to a specific instruction, or set of instructions, or one or more programs with instructions, executed by the processor 110 to perform a function, e.g., one or more of the functions described below. The steps of method 200 are carried out by any one of the exemplary architecture embodiments shown in Figs. 2-4 and 6-7B. Acoustic reflex measurement is initiated either automatically or by a user trigger via a user interface (e.g., a physical button on listening device 105, a prompt or selection button on a smartphone, etc.) at step 210 (e.g., per an initiation module). The listening device 105 generates and sends ultrasound tones with sufficient duration (e.g., 5 seconds) in step 215 as described herein (e.g., with the architecture of the listening device 105, e.g., with any one of the hardware examples of ultrasound tone generation described herein) into one of the ears of the subject (e.g., per an ultrasound tone module). The microphone 130 receives a reflected ultrasound signal in step 220 and processor 110 measures one or more characteristics related to the ear canal equivalent length via a coherent detection method in step 225 (e.g., per a measurement and / or analysis module). More specifically, the ultrasound wave is reflected back out of the ear canal with a certain delay, phase shift and amplitude relative to the sent ultrasound tones. According to the coherent detection method, by mixing (i.e., multiplying) the transmitted and reflected tone signals, mix product tones occur thatDocket No. 2024PF00216- PATENT - can be easily separated from the transmitted and reflected tone signals by bandpass filtering. The amplitude and phase of these mix products are then indicative of the equivalent ear canal length. The coherent detection method described herein is known from domains like telecommunications, radar sensing etc. (also known as quadrature demodulation). The mathematical underpinning can be seen in sections 3.1 and 3.2 of Xiaoran Fan et al., APG: Audioplethysmography for Cardiac Monitoring in Hearables, ACM MobiCom ’23, October 2-6, 2023, Madrid, Spain, which also describes a coherent detection method. In step 230, listening device 105 produces an audible and preferably relatively loud sound e.g. tone burst or shot noise as described above for audible sound generation. The audible sound is sent into one (monaural) or both (binaural) ear canals (green arrow) in step 230 (e.g., per an audible sound module and with any one of the hardware examples of audible sound generation described herein). The audio playback mode can also be reactivated or accessed temporarily (or music or audio data from the device can be accessed directly) to play a short segment of music or other audio data from a connected external device such as an audio player or smartphone to generate the audible sound for this step. In step 235, the system waits for reflex to set in by monitoring time before the next step (e.g., per a time monitoring module), e.g., for a very loud sound, the system will monitor the time for, e.g., 25-35ms before initiating the next step. While the monitored time in this instance may be typical, it should be clear that the monitored time may have values outside of this range. In step 240, steps 215-225 are repeated for performing the same ultrasound measurement of ear canal characteristics (e.g., per a measurement and / or analysis module). Thus, the method includes detecting the equivalent length of the ear canal at different times (before and after the audible sound is transmitted to the subject). In step 245, the system compares the measured ear canal characteristics from step 225 to the measured ear canal characteristics from step 240 (post-audible sound transmission) to determine if the ear canal equivalent length has changed, and hence if acoustic reflex has set in (e.g., per a measurement and / or analysis module and with the processor 110). If there is no change, i.e., the acoustic reflex has not set in, the subject is considered to possibly have hearing loss. In the present disclosure, the equivalent length h or h(t) is interpreted as a function of the acoustic reflex. It is well known from other domains that such coherent detection is robust to noise, enabling high-quality retrieval of tiny variations in h(t) which indicate a change in the equivalent length of the ear canal. The method 200 steps can be repeated for the other ear to measure the acoustic reflex in both earsDocket No. 2024PF00216- PATENT - sequentially. The measurement can within certain limitations (e.g. offering certain stimuli only one-sided and sequentially) be run in both ears simultaneously as well.

[0055] In step 250, the system takes an automated action if the step 245 determines hearing loss if the acoustic reflex does not set in (e.g., per an automated action module and with the processor 110). The automated action taken under step 250 is for example, alerting the subject of the possibility of hearing loss, recommending to the subject to see a specialist, connecting to the user’s smartphone or smartwatch and scheduling an appointment with a hearing specialist, lowering or limiting the sound level of the listening device 105 (e.g., dampen the peaks through DSP monitoring as will be discussed below), recommending a reduction in audio listening or a reduction in sound level if the sound level cannot be automatically lowered by the system, or restart the method 200 if there is an uncertainty with respect to the determination of hearing loss. Headsets with active noise control (ANC) or sound limiters use digital signal processing (DSP) to analyze the incoming sound waves in real time. If the DSP detects a sound wave that exceeds a certain threshold (a "peak") based on the subject’s diagnosis of potential hearing loss, it can apply a reduction in amplitude (volume) or limit the maximum output, effectively dampening the peak to a safer or more comfortable level to avoid further damage to the subject’s hearing.

[0056] In one exemplary embodiment of method 200, the audible sound in step 230 can be a sound programmed into the listening device 105 such as a voice or a system sound confirming certain user interface actions (e.g., installing the earbud into the ear, pause / play, switch ANC on / off etc.). These sounds could be chosen to be usable also as audible stimulus in step 230 above, effectively making the acoustic reflex measurement run fully automatically and unobtrusively in the background without the user noticing.

[0057] Turning to another consideration of the present disclosure in light of the steps in method 200, the acoustic reflex cannot be measured during audio playback enjoyment because it is not advisable to test hearing loss while a subject is listening to audio already. The tympanic membrane should ideally be at rest (i.e., listening device 105 and ambient noise completely or reasonably silent) at the start of the acoustic reflex measurement under the present disclosure because the goal of the acoustic reflex measurement is to measure the variation or change in the equivalent length of the ear canal from tympanic membrane at rest (tmO) to stiffened tympanic membrane (tml). As understood from method 200, the audible sound sent in step 230 to the ear drum is the catalyst thatDocket No. 2024PF00216- PATENT - causes a variation in the equivalent length of the ear canal to occur and to be measured in light of the resulting stiffening of the tympanic membrane. Ambient noise or audio transmission to the subject prior to or during the initial steps (prior to step 230) of method 200 would interfere with an appropriate comparison being made in step 245. Accordingly, the switching circuitry 140 allows the listening device 105 to operate for example in two different modes, audio playback mode and hearing loss screening mode, to ensure that normal audio playback is switched off and does not interfere with or undermine acoustic reflex measurement, e.g., by ensuring that the measurement of the initial characteristics related to the ear canal equivalent length via a coherent detection method in step 225 is not performed when the tympanic membrane is stiff due to audible sound from music being played by the user. Additionally, ambient noise or sound may be detected by the microphone 130 and processor 110 so that the method 200 is suppressed. Additional circuits and methods for maintaining silence include automatic shut-off of certain sound features on the listening device 105. For example, if the listening device 105 has an audible notification circuit and / or function (e.g., battery at 5% notification, shut-off in 1 min warning, or similar audible notifications), such audible notification circuit will be shut off prior to step 230 being executed in hearing loss screening mode. However, some sounds may intentionally remain functional such as those sounds mentioned above for intended use as an audible stimulus in step 230 (e.g., installing the earbud into the ear, pause / play, switch ANC on / off etc.) Switching circuitry 140 includes by way of example a traditional physical switch 160 for selecting between audio playback and hearing loss screening modes of operation, as shown in Fig. 6.

[0058] In a further exemplary embodiment shown in Figs. 7A-7B, an electronic device 170 with a user interface 175 is used to replace the switching circuity 140 with signals directly and wirelessly transmitted from device 170 to receiver 180 for controlling the processor 110 and other components. Electronic device 170 is exemplified as a smartphone, but can take the form of a smartwatch, fitness tracker, health tracker, tablet, desktop computer, or other similar device that communicates with the receiver 180 of listening device 105 via a wireless signal (e.g.., RF, Bluetooth, or similar wireless communication format) to trigger switching between audio playback mode and hearing loss screening mode or switching functionality between different modes or functions, e.g., switching between audible sound generation and ultrasound tone generation. User interface 175 is used to activate or start the hearing loss screening process in connection withDocket No. 2024PF00216- PATENT - method 200. Alternatively, as previously mentioned, microcontroller 145 may be configured for control logic and system management such as for example Bluetooth or other wireless functionality, including communication between device 170 and the listening device 105. Fig. 7C- 7D show alternative embodiments in which the electronic device 170 could also be used to transmit a signal to receiver 180 to control switching circuitry 140.

[0059] As mentioned above, it is important that the tympanic membrane should ideally be relaxed or at rest (i.e., listening device 105 and ambient noise completely or reasonably silent) at the start of the acoustic reflex measurement under the present disclosure because the goal of the acoustic reflex measurement is to measure the variation in the equivalent length of the ear canal from tympanic membrane at rest state (tmO) to stiffened tympanic membrane state (tml). The tympanic membrane may not be at rest at the start of method 200 because of ambient noise (e.g., a loud sound like an emergency vehicle driving by or a lawnmower being started, or simply lower ambient noise that leaks through a bad seal such as a TV or radio playing in the background). Thus, in one embodiment, listening device 105 has noise canceling features to ensure that environmental noise is blocked out, ensuring that the tympanic membrane will be relaxed or at rest. In a further embodiment, listening device 105 is an ANC device such as a headphone or earbud with ANC capabilities. The ANC technology employs a loudspeaker (i.e., actuator) to produce sound (with on / over the ear headphones) close to or (with earbuds) inside the ear canal. It also employs a microphone inside the headphones to capture the actual sound entering the ear including any coincidental and unwanted environmental sound (i.e., noise) bled through the headphone’s shielding enclosure. By ‘subtracting’ the wanted sound signal from the microphone’s signal via signal processing, what remains is the noise. Then, by compensating for (e.g., ‘subtract’) the noise in the loudspeaker signal, it can be eliminated to a large extent. In other words, ANC uses microphones to pick up ambient sound and generate sound waves that are the inverse of those noises. These inverse waves cancel out the incoming noise by destructive interference. ANC is particularly effective at reducing low- to mid-frequency, consistent noises like engine hums, air conditioning, or the sound of a car driving by. ANC headphones also rely on their design (earcup sealing, materials, etc.) to physically block some sound through passive noise isolation. This works better with over-ear headphones in some cases. An ANC device under the present disclosure may optionally include one or more external secondary microphones outside of the device enclosure toDocket No. 2024PF00216- PATENT - obtain a cleaner representation of external unwanted sounds. By inputting this cleaner representation into the ANC algorithm, the noise can be eliminated even further. However, there are still some limitations to ANC - sudden, high frequency sounds such as high-pitched or irregular noises, e.g., a car horn or a loud voice, are harder to block completely. While ANC reduces high frequency sound intensity, it may not eliminate the sound entirely. Thus, listening device 105 includes a silence assurance circuit that listens for high frequency sounds through the microphone 130 prior to step 230 being executed, and if such a high frequency sound is detected, listening device 105 will restart the process under method 200 and prevent the process from continuing for a sufficient time to reset the user’s tympanic membrane to rest (tmO) again.

[0060] In a further alternative embodiment, the listening device 105 includes an external microphone to detect external or ambient noise outside of the listening device 105. If the listening device 105 does not contain noise cancelation features, the system can automatically lock or shut off the hearing loss screening mode in the presence of ambient noise, or alternatively, provide a warning message to the subject that the measurement may be impacted or affected by ambient noise. In a further embodiment, if noise cancelation is available, but simply turned off, the system can automatically turn on noise cancelation in the presence of ambient noise.

[0061] In accordance with various embodiments of the present disclosure, the methods described herein may be implemented using a hardware computer system that executes software programs stored on non-transitory storage mediums. Further, in an exemplary, non-limited embodiment, implementations can include distributed processing, component / object distributed processing, and parallel processing. Virtual computer system processing may implement one or more of the methods or functionalities as described herein, and a processor described herein may be used to support a virtual processing environment.

[0062] Although determining hearing loss using a listening device has been described with reference to exemplary embodiments, it is understood that the words that have been used are words of description and illustration, rather than words of limitation. Changes may be made within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the embodiments. Also, although determining hearing loss using a listening device has been described with reference to particular means, materials and embodiments, it is not intended to be limited to the particulars disclosed; rather evaluating quality of an ultrasoundDocket No. 2024PF00216- PATENT - imaging system extends to all functionally equivalent structures, methods, and uses such as are within the scope of the appended claims.

[0063] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. The illustrations are not intended to serve as a complete description of all of the elements and features of the disclosure described herein. Many other embodiments may be apparent to those of skill in the art upon reviewing the disclosure. Other embodiments may be utilized and derived from the disclosure, such that structural and logical substitutions and changes may be made without departing from the scope of the disclosure. Additionally, the illustrations are merely representational and may not be drawn to scale. Certain proportions within the illustrations may be exaggerated, while other proportions may be minimized. Accordingly, the disclosure and the figures are to be regarded as illustrative rather than restrictive.

[0064] One or more embodiments of the disclosure may be referred to herein, individually and / or collectively, by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any particular invention or inventive concept. Moreover, although specific embodiments have been illustrated and described herein, it should be appreciated that any subsequent arrangement designed to achieve the same or similar purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all subsequent adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the description.

[0065] The Abstract of the Disclosure is provided to comply with 37 C.F.R. §1.72(b) and is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, various features may be grouped together or described in a single embodiment for the purpose of streamlining the disclosure. This disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter may be directed to less than all of the features of any of the disclosed embodiments. Thus, the following claims are incorporated into the Detailed Description, with each claim standing on its own as defining separately claimed subject matter.Docket No. 2024PF00216- PATENT -

[0066] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to practice the concepts described in the present disclosure. As such, the above disclosed subject matter is to be considered illustrative, and not restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments which fall within the true spirit and scope of the present disclosure. Thus, to the maximum extent allowed by law, the scope of the present disclosure is to be determined by the broadest permissible interpretation of the following claims and their equivalents and shall not be restricted or limited by the foregoing detailed description.

Claims

1. Docket No. 2024PF00216- PATENT -CLAIMS:

1. A method of determining hearing loss with a listening device, the method comprising the processor-executed steps of: transmitting an ultrasound tone to a user of the listening device; measuring length of an ear canal of the user after receiving a reflected ultrasound signal; transmitting an audible sound to the user of the listening device; transmitting an ultrasound tone to the user of the listening device and measuring length of an ear canal of the user after receiving a reflected ultrasound signal; comparing the measurement of the length of the ear canal before and after the audible sound transmission; and if there is no change or minimal change in the length, notifying the user of hearing loss or controlling the listening device to limit sound level.

2. The method of claim 1 , wherein the listening device is an over-the-ear headphone, on- the-ear headphone, earbuds, or active noise canceling device (ANC).

3. The method of claim 1, wherein the step of transmitting an ultrasound tone is performed with an ultrasound transducer.

4. The method of claim 3, wherein the step of transmitting an audible sound is performed with a speaker driver and the processor is configurable to switch between transmitting the ultrasound tone with the ultrasound transducer and transmitting the audible sound with the speaker driver.

5. The method of claim 1, wherein the method is activated by an electronic device connected to the listening device, wherein the electronic device is a smartphone, smartwatch, health tracker, fitness tracker, a tablet, or a desktop computer.

6. The method of claim 2, wherein audio playback by the listening device is suppressed by at least one of: switching from an audio playback mode to a hearing loss screening mode viaDocket No. 2024PF00216- PATENT - a switching circuit or suppressing processing of audio playback through one or more computer readable processor executable instructions.

7. The method of claim 1, wherein the length is expressed as an equivalent length modeling the ear canal.

8. The method of claim 7, wherein the modeling of the ear canal is based upon a pipe.

9. The method of claim 7, wherein the ear canal equivalent length is measured via a coherent detection method.

10. The method of claim 1, wherein ambient noise is detected prior to the start of the method and the method is suppressed until ambient noise is no longer present.

11. A listening device comprising, means for transmitting an ultrasound tone to a user of the listening device; a processor for measuring length of an ear canal of the user after a reflected ultrasound signal is received; and a speaker for transmitting an audible sound to the user of the listening device; wherein the processor compares the measurement of the length of the ear canal before and after the audible sound transmission, and if there is no change or minimal change in the length, the processor issues a notification to the user of hearing loss or controls the listening device to limit sound level.

12. The listening device of claim 11, wherein the listening device is an over-the-ear headphone, on-the-ear headphone, earbuds, or an active noise canceling device (ANC).

13. The listening device of claim 11, wherein the means for transmitting an ultrasound tone is one of a speaker driver or an ultrasound transducer.Docket No. 2024PF00216- PATENT -14. The listening device of claim 11, wherein the listening device includes a receiver for wirelessly receiving instructions from an electronic device and wherein the electronic device is a smartphone, smartwatch, fitness tracker, health tracker, tablet, or desktop computer.

15. The listening device of claim 11, wherein the length is expressed as an equivalent length modeling the ear canal based upon a pipe.

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