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Electromagnetic semi-implantable hearing device: phase I. Clinical trials.
T M McGee1, J M Kartush, J C Heide
1Michigan Ear Institute, Farmington Hills 48334.
The Laryngoscope
|April 1, 1991
Summary
A new semi-implantable electromagnetic hearing device offers significant improvements over conventional hearing aids for sensorineural hearing loss. This innovative device provides better sound quality and overcomes issues like acoustic feedback.
Area of Science:
- Otorhinolaryngology
- Biomedical Engineering
- Audiology
Background:
- Conventional hearing aids face challenges like acoustic feedback and limited gain due to sound amplification in the ear canal.
- Previous nonacoustic hearing device alternatives were impractical due to inefficient coupling or high power demands.
Purpose of the Study:
- To evaluate the clinical efficacy and user experience of a novel semi-implantable electromagnetic hearing device.
- To compare the performance of the electromagnetic hearing device against conventional hearing aids in patients with sensorineural hearing loss.
Main Methods:
- Phase I involved coupling an electromagnetic driver with a target magnet affixed to the malleus in six hearing aid users.
- Phase II involved surgically implanting the device in patients with mixed hearing loss, incorporating the magnet into a hydroxyapatite ossicular prosthesis.
Main Results:
- The electromagnetic hearing device demonstrated sufficient gain and output for sensorineural hearing loss.
- Improvements were observed in pure-tone testing and speech discrimination compared to conventional devices.
- Subjective feedback highlighted benefits including no acoustic feedback, effectiveness in noise, and a more natural sound.
Conclusions:
- The semi-implantable electromagnetic hearing device shows promise as an effective alternative to conventional hearing aids.
- Favorable results from Phase I and II warrant further investigation and potential clinical adoption.