Cochlear secures 2 FDA nods for telehealth method to program hearing implants from afar

Cochlear secures 2 FDA nods for telehealth method to program hearing implants from afar

Hear ye, hear ye: Patients using Cochlear’s hearing implants can now undergo routine adjustments and receive virtual counseling from their hearing health providers completely virtually via Cochlear’s newly expanded remote care platform.

The Remote Assist solution allows clinicians and patients to meet using video, audio or online chat. During these virtual consultations, clinicians can make changes to master volume, bass and treble levels, enable new processor settings and discuss any other issues a patient may be having with their implant.

The FDA signed off on the solution for two of Cochlear’s implants in the last month. The agency approved Remote Assist for use with the Nucleus system, which includes a variety of cochlear implants and connected sound processors. Meanwhile, the FDA also issued a clearance allowing the telehealth solution to be used with Cochlear’s Baha bone conduction systems, which are inserted directly into the skull bone to send sound vibrations to the inner ear.

With the pair of regulatory nods, Cochlear will begin rolling out Remote Assist next spring.

The software is joined on Cochlear’s remote care platform by Remote Check, which received its own FDA clearance in April 2020. With that platform, patients can conduct a thorough review of their implant’s performance from the comfort of their own home using only the Nucleus Smart App. After completing a series of tasks that can include uploading several implant site photos, answering questionnaires and undergoing a series of hearing tests, users submit their results to an online portal where clinicians can then access their results.

In total, Cochlear’s telehealth options are designed to cut down on the need for patients to repeatedly go into the clinic for regular reprogramming sessions, to add new features to their implants or to talk through other questions or concerns with their hearing care providers.

“Through Cochlear’s Remote Check and Remote Assist, our innovative and secure remote care solutions further enhance clinical practice by bringing more options for monitoring patient performance and optimizing hearing outcomes remotely—ultimately providing care when and where it’s needed,” said Tony Manna, president of Cochlear Americas.

“Our remote care solutions have been carefully designed and tested to meet rigorous quality and security standards, giving our hearing implant recipients and their hearing care professionals the confidence to receive and deliver quality care outside of a medical office,” Manna added.

Cochlear has long prioritized making implant adjustments and updates broadly accessible, regardless of a patient’s schedule, location or mobility. In 2017, it became the first hearing tech developer to earn FDA approval to deliver programming tweaks via telehealth.

At the time, the agency gave the OK for clinicians to use a telemedicine platform to remotely program the Nucleus cochlear implant sound processors of patients who’d had at least six months of experience with the implant and were familiar with the programming process. The first-of-its-kind approval was granted after Cochlear submitted clinical trial data showing that there were no significant differences in the results of speech perception tests conducted one month after both remote and in-person adjustments.

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