At Affinity Hearing, we have had several patients comment on the new law which Congress recently passed, allowing for the sale of OTC hearing aids. We thought it might be a good idea to clarify the law, so our patients can draw their own conclusions.
On August 3, 2017, the US Senate and House passed H.R.2430, which creates on new over-the-counter class of hearing aids. Here is the actual language of the bill that pertains to hearing aids:
(Sec. 709) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must: (1) provide reasonable assurances of safety and efficacy; (2) establish output limits and labeling requirements; and (3) describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription. The FDA must determine whether premarket notification is required for over-the-counter hearing aids to provide reasonable assurance of safety and effectiveness.
State and local governments may not establish or continue in effect requirements specifically applicable to hearing products that are not identical to FDA requirements and that restrict or interfere with the servicing or sale of over-the-counter hearing aids.
The FDA must update and finalize its draft guidance on hearing products. The guidance must clarify which products are medical devices.
So, what impact will this new law have on hearing aid sales in the US?
Nobody really knows at this time. The FDA has up to 3 years to re-write the hearing aid regulation to add this new class of hearing aids. What we do know is that these hearing aids will be available to the general public without the need of going through a licensed hearing health care professional.
What will OTC hearing aids cost?
It is expected that the cost will be less than hearing aids purchased through the traditional health care system, but like everything else, cost will be driven by demand, available features, and effectiveness.
Will more people seek hearing help because it is now not mandated that they seek medical advice first?
That is the hope, but when people self-diagnose medical problems it raises the possibility that they will miss a potentially dangerous medical condition.
Will people hear as well with OTC hearing aids as those prescribed and fitted by an audiologist?
Undoubtedly some people will and others will not. Because a hearing evaluation will not be required to purchase these instruments, there will not be the opportunity for “tuning” the hearing aids to the individual’s hearing loss. We do not know what types of features they will have, which help people hear better in noisy and difficult environments. It is expected that only people with very mild hearing loss will be able to wear OTC instruments.
How will people get service on their OTC hearing aids?
This is a huge issue. Patients who receive hearing aids through a hearing health care professional know that when they have a dead hearing aid, or when they need an adjustment or tuning based on changes in their hearing loss, the audiologist is there to fix the problem. OTC hearing aids will more than likely have a shorter warranty and getting service will be much more difficult and probably more expensive than the present. Up-front cost savings may dwindle over time and lack of regular service will lead to shorter longevity.
Where will OTC hearing aids be able to be purchased?
Could be anywhere from Walgreens, to Best Buy to a guy on the street. But most audiologists will also carry them, at a price competitive with everyone else. Hearing health care professionals will be able to provide better service and care than an untrained retail clerk. In addition, they will be able to provide health care advice that you will not receive from a sales person.
I’m having trouble hearing now. Should I wait to purchase new aids until the OTC aids are available?
We don’t recommend this. Hearing loss can be a major problem for many people, causing communication problems which affect their lives and that of their loved ones. In addition, untreated hearing loss is linked to dementia. It is important that people seek help as soon as possible when hearing loss is impacting their lives.
Affinity Hearing is here to help you with all your hearing needs. We provide complete hearing health care; from diagnosis of hearing loss, to prescribing and fitting of the customized hearing devices suited for any degree of hearing loss. We carry all major brands of hearing aids and will recommend products that fit your lifestyle and budget. Please call us at 763-744-1190 to schedule a hearing evaluation and consultation.