Sony Electronics said on Wednesday it has started selling its first over-the-counter hearing aids for the U.S. market including an entry-level device priced at about $1,000.
The first two products to debut from the partnership of Sony and WS Audiology, a century-old Danish hearing aid maker, are the CRE-C10 and the CRE-E10 self-fitting OTC hearing aids, which can be customized with a smartphone app, Sony said in a statement.
The Food and Drug Administration in August opened the door to OTC sales starting in mid-October by publishing a final rule.
Sony, a leading provider of wireless earphones, has identified the regulatory change as a chance to use its brand and audio technology to add a new growth driver to its portfolio.
The company said it’s aiming the products at the underserved U.S. hearing aid market. According to data from The National Institute on Deafness and Other Communication Disorders, about 28.8 million U.S. adults could benefit from using hearing aids. Among adults aged 70 and older with hearing loss who could benefit from hearing aids, fewer than 30 percent has ever used the devices. For adults aged 20 to 69, about 16 percent of those who could benefit from wearing hearing aids have ever used them, the data show.
Rival Eargo recently valued the potential OTC market for hearing aids at about $8 billion.
Sony said the app allows the wearer to "self-fit" their hearing aids using pre-defined hearing profiles that can be set to account for ambient noise levels and reduce back and side noise levels, a frequent complaint from hearing aid wearers.
The CRE-C10 sits inside the ear and has a battery life of up to 70 hours of continuous use, while the CRE-E10 has an earbud-like design and a rechargeable battery for wireless charging that delivers up to 26 hours of continuous use, Sony said.
The E10 is also Bluetooth-compatible on iPhones. The CRE-C10 has a suggested retail price of $999.99 per pair and will be available for sale online this month from Sony and from retailers including Amazon, Best Buy and some hearing-care professionals.
The E10 will begin sales this winter at a suggested price of $1,299.99.