This week a new hearing aid goes on the market that costs a fraction of most hearing aids, has FDA approval, and can be bought directly by the consumer without seeing an audiologist. Moreover, it comes from Bose, which has a stellar reputation in the field of sound technology.
Three and a half years ago Bose announced that the FDA had approved a hearing aid that consumers would fit and program themselves, using an app on their smart phone. But no new product appeared, and some wondered if they’d given up.
Last week, surprising many, Bose announced that its SoundControl hearing aid would be available starting on Tuesday May 18th at a cost of $849 per pair. The hearing aids are intended for people with mild to moderate hearing loss. There’s a 90 day trial period. For now they are available only in five states: Massachusetts, Montana, North Carolina, South Carolina, and Texas, but distribution will cover all the states within a year. The aids have a behind-the-ear component and a dome in the ear, and look like a standard hearing aid. For photographs and a more detailed discussion, read Karl Strom’s article in Hearing Review. The image below is from Hearing Review.
The consumer uses the Bose Hear App on a smart phone to personalize the sound levels. The Bose Hear App has just two controls: World Volume (how loud you need it to be to hear in your environment) and Treble & Bass, which allows you to refine the sound according to your needs. The app also allows you to change the direction of the microphones, from Everywhere to Front, which is helpful in noise. You can also change the Left/Right Ear balance.
The aids use standard 312 hearing-aid batteries, with a battery life of up to four days depending on how and how often the hearing aid is used. (If you are already a hearing-aid user, you know that some batteries seem to have a lifespan of about 10 minutes, but that’s the battery’s fault, not the device’s.) Many people prefer rechargeable batteries.
This hearing aid is not for me or for most readers of my blog, who tend to have more severe loss. But they may be for those who could benefit from a hearing aid but are deterred by cost ($2400 per aid, on average). You can go on the Bose product page and take a hearing test to see if the Bose aid is right for you. Consumers can also try out the hearing aid virtually, wearing headphones, and see how the fitting works.
Since the product is not yet available, there are no user reviews, but I’d love to hear from anyone who tries them out. Just add a comment to this post. A study done by Bose with Northwestern comparing the Bose to prescription hearing aids found that users were happier with Bose’s sound quality than they were with prescription aids.
The Northwestern study also found no difference in hearing-in-noise performance and customer satisfaction in those using prescription-fitted hearing aids and the Bose. Abram Bailey of Hearing Tracker noted that the product used in the study had closed earbud-like tips. The marketed product has tips more like a standard dome that fits loosely in the ear. Bailey wrote that open tips provide less bass, and a “fundamentally different sound quality.” He would like to see Bose replicate its findings using the patented SoundControl product.
Standard hearing aids offer many features that the Bose does not. These include Bluetooth compatibility. You program the hearing aids using Bluetooth (and the Bose app) but you can’t listen to phone calls or stream music or podcasts the way you can with Made-for-iPhone or Made -for-Android aids. Hearing Review suggested that this decision may have been made to provide for longer battery usage. They also have no telecoil, which means you can’t take advantage of hearing loops and other assistive listening devices without an additional streamer.
The Bose SoundControl is not an over-the-counter hearing aid. The FDA approved it under its DeNovo review pathway, for devices for which nothing like it has previously been marketed. OTC Hearing Aids have been delayed again and again, and are not on the 2021 spring regulatory agenda, which covers reviews scheduled through October. “If the FDA doesn’t address OTC hearing aids during the current session, wrote Abram Bailey, the timeline would be pushed back to mid-2022 at the earliest.(The original review period was supposed to conclude in August 2020.) See below for a more detailed analysis of how the FDA schedule might work.
I’m all in favor of hearing aids being as widely used as possible. Bose’s new hearing aid may be a combination of the right price with the right technology at the right time. Over the years, as the Bose consumer ages and experiences more severe loss, this hearing aid may turn out to have been a gateway device. But the earlier you treat, the better. If the Bose introduces hearing aids to people who then go on to need (and buy) standard hearing aids, that’s good for everyone.
Footnote on FDA and OTC hearing aids, from Hearing Tracker:
“If the FDA doesn’t address OTC hearing aids during the current session, the timeline would be pushed back to mid-2022 at the earliest. Once the rulemaking meeting occurs, a ~60 day public comment period begins, after which FDA has up to 180 days to issue the final regulations. Conservatively, there is an ~8 month delay from rulemaking meeting to regulation issuance, so if FDA addresses OTC in the Fall 2021 session, we could expect to see new regulations anywhere from June 2022 to February 2023.”
For more about living with hearing loss, read my books “Smart Hearing: Strategies, Skills and Resources for Living Better With Hearing Loss” and “Shouting Won’t Help: Why I and 50 Million Other Americans Can’t Hear You.” Both are available as ebook and paperback on Amazon.com.