FDA Approves Bluetooth Enabled Cochlear Implants

Image courtesy of Cochlear Americas

The FDA has approved a sound processor used in cochlear implants so profoundly deaf users can connect the implants to Bluetooth low energy audio systems used in outside venues.¹ The Cochlear Nucleus 8 Sound Processor, according to its developer, Cochlear Limited, uses Bluetooth-enabled low energy (LE) levels that can automatically adjust to the wearer’s environment and adjust the person’s listening settings. Cochlear, based in Lone Tree, Colo., also received FDA approval for the software supporting the implant, including the smart app.

The technology will only work in those venues, like gyms, sporting arenas and restaurants, that are equipped with Bluetooth LE, also called Auracast. The technology also allows the wearer to connect to consumer electronics.

The prosthesis, according to Cochlear, can reduce background noise so that the wearer can better enjoy face to face conversations. Implant wearers will be able to control their processor settings from the downloaded app on their phone.

The new implant is also smaller and lighter than other Cochlear implants, the company says–15% smaller and 13% lighter.

The cochlear implant provides “useful hearing” in those with severe and/or profound hearing loss. By bypassing the defective cochlea, or inner ear, the implant reaches the brain’s auditory centers via electrical stimulation.

The FDA also approved the new sound processor and the two software devices for use in Cochlear’s Nucleus 22 implant for children.²

References

1. Press release. FDA approves Cochlear's Nucleus 8 Sound Processor, smaller, smarter, better connected cochlear implant technology. Nov. 1, 2022https://www.prnewswire.com/news-releases/fda-approves-cochlears-nucleus-8-sound-processor-smaller-smarter-better-connected-cochlear-implant-technology-301664607.html
2. FDA. PMA Monthly approvals from 10/1/2022 to 10/31/2022. https://www.fda.gov/media/163305/download