Hearing impairment rates for U.S. adults vary significantly with age, according to the National Institute on Deafness and Other Communications Disorders. For example, while only 2% of adults aged 45 to 54 have a disabling hearing loss, the rates climb to 8.5% for ages 55 to 64, nearly 25% for people aged 65 to 74, and 50% for people 75 and older. Most people who could benefit from hearing aids do not use them. Only 16% of adults aged 20 to 69 and 30% who are 70 or older have ever used hearing aids.

High costs and stories of dissatisfaction from those who do use hearing aids deter many from even getting tested. Non-medical hearing improvement devices for mild impairment are legal and, thanks to the Over-the-Counter (OTC) Hearing Aid Act, the hearing device landscape is changing dramatically. We’ve written about Nuheara’s IQbuds Boost and the Bose Hearphones nonprescription wearables for people with noticeable but mild to moderate hearing impairment. Both companies have been careful to avoid referring to their products as “hearing aids.”

A recent Food and Drug Administration (FDA) news release may alter the field for hearing wearables. The FDA recently announced that it allowed Bose to market The Bose Hearing Aid. The FDA release delineates the significance of the Bose approval, “This is the first hearing aid authorized for marketing by the FDA that enables users to fit, program and control the hearing aid on their own, without assistance from a health care provider.”

The FDA categorizes the Bose wearable as a “user-fitted wireless air conduction hearing aid.” After stating that existing laws in some states might require that hearing aids are allowed for purchase only from licensed hearing aid dispensers (italics indicate the FDA’s language), the release mentions proposed regulations for the new OTC law. In deciding to authorize the sale of the Bose Hearing Aids, the FDA considered data provided by Bose from clinical studies of 125 patients. The data indicated that not only were the outcomes of the Bose self-fitting device comparable to professionally fitted hearing aids but also that the patients generally preferred the Bose settings over the professional settings.

You won’t find any mention of the Bose Hearing Aid on the Bose website. We don’t know this for sure, but our guess is the company is being cautious about releasing any language or news about the upcoming product until it’s ready for sale. Due to the wording of the FDA release and to Bose’s high profile, any company statements about or promotion of the Bose Hearing Aid will likely face scrutiny by representatives of the traditional medical hearing profession.

As shown by the earlier failures of Doppler Labs and Human Inc., developing new hearables is difficult and bringing them to market may even be tougher. Hopefully, the FDA’s unmistakable intent to open the field for OTC self-fitting hearing aids will help Bose, Nuheara, and others bring new products to the market that needs them.