Transtympanic Inner Ear Stimulation for Tinnitus
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Solution Overview
Problem
Current treatments for tinnitus, such as sound therapy and cochlear implants, are only partially effective, and there is a lack of safe and universally accepted devices for electric stimulation, which poses challenges in activating deafferented auditory nerve fibers and ensuring safety and practicality in tinnitus treatment.
Innovation Solution
A semi-implantable or fully implantable electrical stimulation system that delivers electrical stimulation to the inner ear through a transtympanic approach, using an electrode in contact with the round window membrane and a microprocessor-controlled system for safe and effective tinnitus suppression, allowing for user-controlled stimulation and minimal invasive implantation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If sound therapy is used to treat tinnitus, then it is non-invasive and safe, but it is only partially effective because acoustic stimulation cannot activate deafferented auditory nerve fibers
Solution Approach 1:
The patent replaces acoustic stimulation (sound waves) with electrical stimulation to activate auditory nerve fibers. The electrical stimulation system uses electrodes to deliver controlled electrical currents directly to the inner ear structures, substituting the mechanical/acoustic approach with an electrical one that can more effectively activate deafferented nerve fibers.
Solution Approach 2:
The patent changes the stimulation parameter from acoustic intensity to electrical current characteristics (amplitude, frequency, pulse width). By controlling electrical parameters rather than acoustic parameters, the system can directly target and activate specific auditory nerve fibers that acoustic stimulation cannot reach.
2Reliability
If cochlear implantation is performed to restore hearing and suppress tinnitus, then tinnitus suppression is achieved for majority of patients with severe hearing loss, but it is invasive and not suitable for most tinnitus patients
Solution Approach 1:
The patent applies partial electrical stimulation to the inner ear structures (round window membrane, promontory, or cochlear nerve) without requiring full cochlear implantation. This partial action provides sufficient tinnitus suppression for many patients while avoiding the complexity and invasiveness of complete cochlear implant surgery.
Solution Approach 2:
The patent uses the round window membrane or middle ear structures as an intermediary pathway to deliver electrical stimulation to the inner ear. This intermediary approach allows electrical access to deep inner ear structures without requiring direct surgical implantation into the cochlea, thereby reducing invasiveness.
3Reliability
If transtympanic electrical stimulation is used to activate detached nerve fibers, then it can potentially treat tinnitus, but there is no clear scientific rationale and lack of unified protocols
Solution Approach 1:
The patent incorporates feedback mechanisms where patient response to stimulation is monitored and used to adjust stimulation parameters. This feedback loop allows optimization of treatment protocols based on individual patient responses, helping to establish evidence-based guidelines for transtympanic electrical stimulation.
Solution Approach 2:
The patent employs dynamic adjustment of stimulation parameters (intensity, frequency, duration) based on real-time patient feedback and response. This dynamic approach allows the treatment protocol to adapt to individual patient needs, contributing to the development of flexible yet standardized treatment guidelines.
4Reliability
If electrical stimulation is applied to treat tinnitus, then it can activate auditory nerve fibers, but safety concerns arise regarding potential damage to hearing
Solution Approach 1:
The patent implements safety margins and protective measures in the electrical stimulation protocol before potential harm can occur. This includes setting maximum intensity limits, using charge-balanced pulse waveforms, and monitoring for adverse effects, thereby cushioning against potential hearing damage while maintaining therapeutic effectiveness.
Solution Approach 2:
The patent uses real-time monitoring and feedback to detect early signs of potential hearing damage or adverse effects. When threshold values or safety criteria are approached, the system automatically adjusts or terminates stimulation, preventing harmful effects while maintaining therapeutic benefit.
5Ease of manufacture
If existing stimulators for pain management are used for tinnitus treatment, then they are available for use, but they lack specific design for tinnitus and provide unstable electrode contact
Solution Approach 1:
The patent designs electrodes with local quality optimized for specific inner ear structures (round window membrane, promontory, or cochlear nerve). The electrode geometry, material, and contact surface are specifically tailored to the local anatomical characteristics of the target site, ensuring stable and reliable contact that generic pain management stimulators cannot provide.
Solution Approach 2:
The patent segments the stimulation system into specialized components including custom-designed electrodes, isolators, and control circuits optimized for tinnitus treatment. This segmentation allows each component to be optimized for its specific function, improving overall system reliability and electrode contact stability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system achieves complete suppression of tinnitus in some patients, with a high degree of safety and effectiveness, including prolonged residual inhibition in several subjects, demonstrating its potential as a viable treatment option for tinnitus.
Implementation Method 1
an electrode for directly contacting a round window membrane of an ear; and a microprocessor disposed in a housing portion to create a receiver, wherein the microprocessor is operatively connected to the electrode. The microprocessor sends a signal to the electrode to cause the electrode to deliver electrical stimulation to the round window membrane
Data Source
AI summary
An electrical stimulation system that provides for transtympanic stimulation of the inner ear that can be used for safely and effectively treating tinnitus. The electrical stimulation system of the present invention may be fully implantable or partially implantable. The system features an electrode placed on the round window membrane. An external portion provides the power to the electrode, which can stimulate the inner ear via the round window as needed by the patient. The present invention also features methods of treating tinnitus using the electrical stimulation system described herein.