Introduced in Congress a few months ago, the Over-the-Counter Hearing Aid Act of 2017 was approved by the Senate and signed into law by the president in August. The bill will allow people with mild-to-moderate hearing loss to purchase hearing aids much in the same way they would buy a pair of reading glasses, without first getting a doctor’s prescription or consulting with an audiologist. The Food and Drug Administration will now have three years to create a new regulatory category for over-the-counter hearing aid products.
The change has opened up the hearing aid market to tech companies, and Apple already has plans to develop an assistive listening device. Although the bill is intended to improve access to better hearing, many hearing health experts are concerned that allowing consumers to diagnose and treat their own hearing loss with lower quality aids could do more harm than good. Read on for a closer look into this new law, and why it is still important to seek the advice of a licensed hearing professional.
The Over the Counter Hearing Aid Act
The bill was part of the larger Food and Drug Administration Reauthorization Act, which was passed by the House and Senate with bipartisan support. This act revises and extends the user-fee programs for prescription and generic drugs, as well as medical devices.
The new class of hearing aids would be regulated by the FDA in a similar way to other medical devices, but there has been intense debate over what level of safety, labeling and consumer protections will be included within the FDA’s new OTC hearing aid category. The Hearing Industries Association (HIA) has been battling the Consumer Technology Association for higher levels of safety and consumer protection (such as output limits), as well as manufacturing and performance standards. The FDA is expected to hold several hearings before publishing the new regulations. The organization will also need to clarify which products meet the definition of a Personal Sound Amplification Product (PSAP) or hearing aid.
The dangers of self-diagnosis
Although the bill includes a certain amount of safety regulations, audiologists and hearing care advocates worry that using hearing aids without the help and guidance of a professional could prove ineffective or even harmful, especially for those with more serious levels of hearing loss.
The American Speech-Language Hearing Association (ASHA) and the HIA have both shared their concerns about the new legislation and its potential impact on those with moderate-to-severe hearing loss.
“Greater degrees of hearing loss are serious medical conditions with broader health implications,” ASHA President Gail J. Richard said recently. “People who experience greater than a mild degree of hearing loss could take the misguided step of trying to seek relief via OTC solutions. A better course of care would involve treatment overseen by a certified and licensed audiologist.”
Indeed, every hearing loss is unique, and requires thorough analysis, diagnosis and specialized treatment for the best results. Few people are able to diagnose their own level of hearing loss with complete accuracy, and whether it favors one ear or occurs equally in both ears. In some cases, hearing loss could be a temporary symptom of a more serious underlying medical condition that could prove dangerous if ignored. It could also be the result of a less harmful and treatable condition such as impacted ear wax. That’s why many hearing care experts across the country still believe that untrained consumers should not be responsible for treating their own hearing loss.
Serious medical conditions aside, there is another problem with self-diagnosis and treatment of hearing loss. Usually, hearing aids require small adjustments to find the ideal fit and fine-tune the sound levels. Hearing care professionals are concerned that first-time users may be discouraged from treating their loss simply because the fit and amplification are incorrect.
Officials have also expressed concern that over-the-counter hearing aids may be used to treat pediatric hearing loss, though they will technically be restricted to adults. Hearing loss in a child is always a serious issue and should be treated with the advice of a doctor and hearing health expert.
For the best outcome, let a professional help
Hearing Wellness Solutions offers free hearing testing, hearing aid evaluations and fittings, hearing aid reprogramming, maintenance repairs and more. If you would like to get on the path to better hearing, please schedule a consultation with our friendly hearing instrument specialist today.
