There’s been a lot of talk about over-the-counter hearing aids, as they are geared for a nationwide rollout beginning sometime in 2020. With around 20 percent of people in Iowa, Minnesota and South Dakota experiencing hearing loss, the ready availability of a lower-cost alternative to physician-prescribed hearing aids appears, on the surface, to be a good thing. But it could actually prove detrimental to some patients with hearing loss.
The Good, the Bad and the Over-the-Counter Hearing Aid Act
The Over-the-Counter Hearing Aid Act of 2017 was sponsored by Senator Elizabeth Warren (D-MA) with the goal of making hearing aids more affordable and easily available. The language of the law is very specific; hearing aids must meet the following criteria in order to be sold directly to consumers:
- Provide reasonable assurances of safety and efficacy
- Establish output limits and labeling requirements
- Describe requirements for the sale of hearing aids in-person, by mail or online, without a prescription
When will new OTC hearing aid guidelines be issued?
Once the law was passed, it was sent to the Food and Drug Administration, who were tasked with developing a set of guidelines determining how to carry it out.
The FDA should be ready to issue those guidelines soon (possibly as early as January), meaning over-the-counter hearing aids could start hitting retail shelves around August 2020.
Does the OTC Hearing Aid Act help patients?
There are pros and cons associated with the OTC Hearing Aid Act. Patients with hearing loss will be empowered to take charge of their own hearing health; they can bypass an examination by an audiologist and buy new hearing aids directly from a retailer.
A retail category of hearing devices already exists, though they cannot legally be labeled as such quite yet; they are called personal sound amplification products (PSAPs). Provided they meet FDA standards, these will likely be marketing as hearing aids beginning next year. The convenience, easy availability and lower costs will likely mean more people with hearing loss will seek treatment.
Are OTC Hearing aids as effective as prescribed ones?
The drawbacks to over-the-counter hearing aids are pretty compelling, too. These hearing aids are really only targeted for people with mild to moderate forms of hearing loss, but without a comprehensive hearing evaluation administered by a qualified hearing specialist, it’s impossible for the average consumer to reliably understand the extent of their hearing impairment. Any money saved by buying from a retailer won’t matter if the hearing aids aren’t powerful enough for their specific hearing loss.
Let’s use reading glasses as an analogy: if your vision is impaired, you need a thorough examination from an optometrist to determine appropriate glasses. But if you just need help reading fine print, an over-the-counter pair of reading glasses from any drugstore will be fine.
How accurate are over-the-counter hearing aids?
Over-the-counter hearing aids will have factory presets for hearing loss, but these won’t be precise enough for most users.
Cynthia Hogan, PhD, audiologist and director of the Mayo Clinic’s hearing program in Rochester, MN, explains, “A hearing aid that’s fit by a professional is fit to a prescriptive target based on scientific research so that the volume is set to how someone hears at those exact frequencies.”
The professional fitting process performed by an audiologist, and subsequent fine-tuning during crucial follow-up appointments, are instrumental in ensuring patients get hearing aids customized to their specific needs.
Does self-diagnosis miss the underlying cause of hearing loss?
Another problem with skipping a visit to the audiologist’s office is the fact that hearing loss has many possible causes. It’s important to determine the reason for your hearing impairment; an underlying disease or health disorder might require treatment, without which hearing aids might not offer much benefit. And you’ll be at risk for long-term health complications if your medical condition is serious.
If you suspect you have hearing loss, visit an audiologist for a complete and accurate diagnosis.
It’s difficult to gauge the full impact over-the-counter hearing aids will have on the industry itself and the benefits they’ll provide patients. If you are experiencing signs of hearing loss but haven’t had a comprehensive evaluation by a qualified professional, schedule an appointment with an audiologist—even if you’re hoping to take advantage of OTC hearing aids.