Bose recently announced the company’s FDA-cleared SoundControl Hearing Aids. The devices will be available for purchase in five states this month. Starting May 18, customers in Massachusetts, Montana, North Carolina, South Carolina, and Texas will be able to buy SoundControl Hearing Aids for $850. The OTC hearing aids will have dedicated Bose support and come with 90-day free trial. Sales in other states will follow, but Bose did not indicate when nationwide availability will occur.

The SoundControl Hearing Aids are the next step in Bose’s 6-year technology trail after a 2016 FDA decision to stop enforcing hearing aid regulations that required a medical examination or special waiver in order purchase hearing aids. The FDA move followed a study that showed only 20% of the then 30 million people in the U.S. with hearing impairment actually sought help. People with hearing issues resisted buying hearing aids due to high cost (estimated at more than $2,000 per ear). The intent of the FDA move was to enable people with mild to moderate hearing loss to buy hearing aids without consulting medical specialists.

Bose was one of several companies that responded to the FDA statement by undertaking development of less expensive hearing assistance devices. Several companies pulled out before or shortly after releasing hearing devices, but those that did make it to market included Bose Hearphones and Nuheara IQ Buds. We were not able to obtain Hearphone review samples but the IQ Buds were impressive.

We wrote in October 2018 that the FDA cleared The Bose Hearing Aid for sales without a medical examination. We also noted at the time that we could find no reference to the device on the Bose site. Bose refers to its new SoundControl Hearing Aids as the first FDA-cleared direct-to-consumer hearing aids. It seems pretty clear that the SoundControl devices are the release version of work-in-development that was previously called The Bose Hearing Aid.

The SoundControl Hearing Aids integrate Bose CustomTune technology that lets users personalize the hearing aid settings on their own using a mobile app. Wearers can also adjust ambient sound levels and finetune frequency amplification based on their needs. Similar to settings in the latest Nuheara IQBuds Max devices, Bose SoundControl Hearing Aids can focus directly in front of the user to help hear conversations. There are also adjustable preset mode for different listening environments. Nuheara offers the above features, but Bose also has dedicated support through which users can set up one-to-one video appointments for help adjusting their hearing aids.

The Bose SoundControl Hearing Aids use hearing aid industry-standard 312 zinc-air batteries. Eight batteries come with the hearing aids. Each battery is rated to last up to four days when used 14 hours per day. The Bose SoundControl apps are iOS and Android compatible and use low-energy Bluetooth wireless connectivity with the mobile app. The Bose news release makes no mention of using the hearing aids with smartphones for streaming music or to make and take phone calls.

Bose cites a 2020 Northwestern University study of hearing devices using a Bose Prototype device that physically resembles the Bose Hearphones. The study showed there was no difference between users who adjusted their own hearing amplification parameters with a mobile app and users whose settings were adjusted by audiologists.

It’s significant the Bose is calling its devices hearing aids. The naming blurs the line between hearing assistance devices for mild to moderate hearing loss and hearing aids for moderate to profound loss. We look forward to hearing more about Bose’s work in this field.