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Semi-implantable middle ear electromagnetic hearing device for sensorineural hearing loss
A J Maniglia1, W H Ko, S L Garverick
1Department of Otolaryngology-Head and Neck Surgery, Case Western Reserve University School of Medicine, University Hospitals of Cleveland, Ohio, USA.
Ear, Nose, & Throat Journal
|May 1, 1997
Summary
A semi-implantable middle ear electromagnetic hearing device shows promise for moderate to severe sensorineural hearing loss. Animal studies confirmed biocompatibility, with a redesigned antenna for human trials.
Area of Science:
- Biomedical Engineering
- Otolaryngology
- Medical Devices
Background:
- Moderate to severe sensorineural hearing loss impacts many adults, often due to aging (presbycusis).
- Current hearing aids have limitations, necessitating innovative implantable solutions.
Purpose of the Study:
- To evaluate the safety, reliability, and efficacy of a semi-implantable middle ear electromagnetic hearing device (SIMEHD).
- To compare the performance of the SIMEHD against traditional acoustic hearing aids.
Main Methods:
- The SIMEHD system comprises external (microphone, amplifier, RF components) and internal (receiver, electronics, coil, magnet) units.
- Pre-clinical evaluation in cats demonstrated biocompatibility and functionality, with minor antenna issues leading to redesign.
- Surgical implantation technique in the human attic and mastoid antrum is detailed.
Main Results:
- Animal studies showed the SIMEHD is biocompatible and functional, surviving chronic implantation for an average of 9.6 months.
- A wire breakage issue in the internal antenna was identified and addressed through redesign for human use.
- The device utilizes biocompatible materials designed for long-term implantation.
Conclusions:
- The SIMEHD is a viable candidate for clinical trials in patients with sensorineural hearing loss.
- Further research will focus on objective and subjective audiologic and psychoacoustic evaluations in human patients.