Several months ago, the Food and Drug Administration Reauthorization Act of 2017 was signed into law. This legislation includes the Over the Counter Hearing Aid Act designed to provide consumers with over-the-counter (OTC) hearing aids that are more cost-effective and more accessible.
According to The Hearing Review, “the new legislation will require the FDA to create and regulate a category of OTC hearing aids to ensure they meet the same high standards for safety, consumer labeling, and manufacturing protection that all other medical devices must meet. It mandates the FDA to establish an OTC hearing aid category for adults with ‘perceived’ mild-to-moderate hearing loss within 3 years of passage of the legislation, and finalize a rule within 180 days after the close of the comment period.”
The uncertainty of the regulatory path, combined with a 3-year window for the FDA to establish a new category for OTC hearing aids, may put accessibility years down the road for today’s hearing aid consumers. It is a long wait, but the potential cost-savings for hearing loss patients could make these hearing aids more accessible to more people, and that is a worthwhile goal.
The long-term launch timeline for OTC hearing aids provides valuable time for research to evaluate if these products live up to certain standards and if adoption by consumers is likely. Recent information raises some concerns about wide adoption of hearing devices without professional guidance, but more research is needed on the subject. Some interesting research on the subject has come to light, illustrated in the brief descriptions and links below:
An Indiana University study, published in the American Journal of Audiology, found lower adoption rates for the participant group that self-purchased hearing devices (55%), as compared to adoption rates for the audiologist-guided participants (81%). Both groups were compared to a placebo control group which had an adoption rate of 36%.
Healthy Hearing conducted two surveys to assess potential adoption of OTC hearing aids.
Survey Finds Consumers Wary of Over-the-Counter Hearing Aids: The first survey conducted by Healthy Hearing concludes that “consumers value the services of hearing care professionals, and there is still an important place for their work.”
Consumers value professional care in a post-OTC hearing aid world: Results of the second survey found, “when it comes to a professionally-administered hearing test, a full 88.33 percent of the respondents to the HCP survey said it is either ‘very important’ or ‘absolutely important.’ A majority, 85.32 percent, said having a hearing care professional select the right devices for their specific needs is either ‘very important’ or ‘absolutely important.’ Finally, 83.14 percent said follow-up care provided by a hearing care professional is ‘very important’ or ‘absolutely important’ to success with hearing aids.”
A professional hearing evaluation is a key step to properly match a hearing loss consumer with the right product. While many people experience hearing loss, individual hearing loss is unique to each person.
The bottom line is that hearing aids, whether OTC or not, will do absolutely no good for anyone if they sit unused. The support provided by a professional regarding testing, fit, use, care, adjustments, and coaching may be the key to higher adoption rates. Currently, the path to using a hearing aid involves patients and providers working together to choose, then customize, the right device based on their type of hearing loss, budget, and lifestyle goals. Schedule an appointment with us today for a hearing evaluation and personalized hearing healthcare plan.