Initial clinical experience with a totally implantable cochlear implant research device

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Neuroscience

Background:

• Sensorineural hearing loss affects millions globally, necessitating advanced audiological solutions.
• Cochlear implants offer significant hearing restoration for severe-to-profound cases.
• The development of totally implantable cochlear implants (TIKI) aims to enhance user convenience and aesthetics.

Purpose of the Study:

• To assess the safety, effectiveness, and performance of a research totally implantable cochlear implant (TIKI).
• To evaluate the audiological outcomes and user experience with TIKI in both "invisible hearing" and conventional modes.

Main Methods:

• A limited trial involving three adult subjects with severe-to-profound sensorineural hearing loss at a tertiary referral center.
• Subjects received a research TIKI with a rechargeable battery and internal microphone, tested in both TIKI-only and conventional external processor modes.
• Speech perception, device performance, and user-reported outcomes were monitored over 12 months post-implantation.

Main Results:

• No surgical or postoperative complications were observed in the three subjects.
• All subjects demonstrated improved speech perception scores compared to preoperative levels.
• Speech perception in the "invisible hearing" mode was lower than in the conventional external processor mode due to reduced microphone sensitivity and some body noise interference.

Conclusions:

• The research TIKI is a safe and potentially effective device for hearing restoration, overcoming previous developmental challenges.
• Subjects reported benefit from routine use of the TIKI, despite the performance difference between listening modes.
• The internal rechargeable battery demonstrated effective low-power design and long potential battery life.