Recent legislation passed by Congress will make a new category of hearing aids available over the counter (OTC) once the bill is signed into law by the president and fleshed out with Food and Drug Administration regulations.
The bill, called the Over-the-Counter Hearing Aid Act of 2017, will allow the retail sale of prescription-quality hearing aids for adults with perceived mild to moderate hearing loss — without the crucial involvement of an audiologist or medical doctor.
What does this mean for you? Read on to learn more about this legislation and its potential impact on your hearing care.
- Q: When will the Over-the-Counter Hearing Aid Act of 2017 go into effect?
A: The law will become effective as soon as it’s signed by the president, but the FDA must first propose and finalize applicable regulations before the OTC devices actually hit the market. The FDA has up to three years to finalize the regulations but most experts believe it will take 1-2 years.
- Q: What will the FDA regulations address?
A: The regulations will apply certain safety, labeling, and manufacturing requirements to the new category of hearing aids, holding them to the standards of other medical devices.
- Q: Aren’t OTC hearing aids already available?
A: Only personal sound-amplification products — wearable electronics neither FDA-approved nor recommended to treat actual hearing loss — are currently available over the counter.
- Q: Who sponsored the legislation?
A: The final legislation resulted from bipartisan-led companion bills from the House and Senate, with each proposed bill having had joint Democratic and Republican sponsors.
- Q: What are the pros of this legislation?
A: Supporters believe the legislation will expand consumer access to more affordable hearing technology, motivate more people to get hearing help, and spur more product innovation.
- Q: What are the cons?
A: Access to hearing care is vital, but unfortunately the bill enables self-treatment for a serious physical condition that licensed professionals are more suited to evaluate, diagnose, and treat. The current wording in the legislation of PERCEIVED mild to moderate hearing loss needs to be further defined and quantified.
- Q: How much will the OTC hearing aids cost?
A: OTC devices may initially cost less than higher-quality technology sold in a clinical setting, but in the long run, skipping expert help could prove more costly to your health and your wallet.
- Q: How can I determine whether I have mild or moderate hearing loss?
A: Hearing loss is measured by factors such as the lowest intensity of sound you can hear — 26–40 decibels for mild, 41–55 for moderate, and so on — and is best confirmed with a hearing test.
- Q: How can I add my voice to this issue?
A: Contact your Congressional representatives to help shape future FDA regulations regarding this legislation, or comment to the FDA directly when rule-making gets underway.
- Q: How can I best maintain good hearing health?
Limit exposure to excess noise, avoid self-treatment, and schedule regular hearing checks with a licensed professional — just as you would for your eyes or teeth. For optimal hearing health, nothing takes the place of seeing your local audiologist.
If you have questions about OTC hearing technology, signs and symptoms of hearing loss, or the dangers of self-treating for hearing impairment, call us today at (757) 847-5835. We’re here to answer your questions and address any concerns.