Man placing his hand to his ear

The Food and Drug Administration for the first time has authorized for marketing a hearing aid that users can fit, program and control without help from a healthcare provider.

The Bose Hearing Aid is intended to amplify sounds for adults who are aged at least 18 years and have perceived mild to moderate hearing loss. It can be adjusted through a mobile application on a smartphone.

Before authorizing marketing of the device, the FDA reviewed data from clinical studies involving 125 people. Outcomes with the self-fitting hearing aid were comparable, on average, to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit, the agency said.

The new hearing aid still must comply with applicable federal and state laws regarding the sale of hearing aids, including state laws that might require hearing aids to be purchased from or dispensed by a licensed hearing aid dispenser. The FDA said it is in the process of drafting proposed regulations for a new category of over-the-counter hearing aids.

Approximately 37.5 million adults aged 18 or more report having some trouble hearing without a hearing aid, ranging from “a little trouble” to “deaf,” according to the FDA. Hearing loss may almost double in the coming decades, found a study published last year in JAMA Otolaryngology – Head & Neck Surgery. In 2020, the researchers said, 55% of all adults with hearing loss will be aged 70 or more years; in 2060, that statistic will be 67%.

Bose already sells Hearphones, which the company describes as “conversation-enhancing headphones” meant to help people hear in loud environments.

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