A novel bone conduction implant (BCI): engineering aspects and pre-clinical studies

Area of Science:

• Biomedical Engineering
• Otolaryngology
• Rehabilitative Technologies

Background:

• Percutaneous bone anchored hearing aids (BAHA) are effective for conductive/mixed hearing loss but have drawbacks like infections and implant loss.
• Patient stigma and surgical complications limit the widespread adoption of current bone conduction devices.
• A novel, skin-intact bone conduction implant (BCI) system has been developed to address these limitations.

Purpose of the Study:

• To describe the engineering principles of a new BCI system.
• To present preclinical results comparing the new BCI system to conventional BAHA.
• To evaluate the audiological performance and safety profile of the novel BCI.

Main Methods:

• Development of a novel BCI system with a non-screw attachment and encapsulated transducer.
• Laser Doppler vibrometer measurements on three cadaver heads.
• Comparative analysis of sound transmission (output acceleration levels) at the ipsilateral and contralateral promontory for both BCI and BAHA systems.

Main Results:

• The new BCI system achieved 0-10 dB higher maximum output acceleration at the ipsilateral promontory compared to ear-level BAHA at speech frequencies.
• The BCI system demonstrated considerably lower maximum output acceleration at the contralateral promontory than BAHA.
• The BCI system's non-screw attachment and skin-intact design were successfully implemented.

Conclusions:

• The novel BCI system shows promising audiological performance, with potentially superior sound transmission to the inner ear.
• The BCI system design avoids skin complications and implant loss associated with percutaneous BAHA.
• Further clinical studies are warranted to validate the efficacy and long-term outcomes of this innovative BCI system for hearing rehabilitation.