The FDA has not approved any over-the-counter hearing device despite claims some products have “FDA Registration Certificate”
May is Better Hearing and Speech Month. Iowa Attorney General Tom Miller is taking this time to warn consumers to be wary of companies selling potentially faulty and unregulated over-the-counter hearing devices.
The Iowa Attorney General’s Office has received consumer complaints about over-the-counter medical hearing devices following the relaxation of rules and restrictions on the sales of hearing aids in 2016.
Companies selling these over-the-counter hearing devices promise an inexpensive alternative to a medically approved hearing aid. In reality, these devices are often actually Personal Sound Amplification Products, not FDA-approved hearing devices, and leave consumer with little more than a sound amplifier.
In addition to offering a lower price tag, companies selling these over-the-counter devices often market their products with an “FDA Registration Certificate,” implying the device was reviewed and approved by the FDA. According to the FDA, there are no approved over-the-counter hearing devices on the market.
Unlike traditional healthcare professionals that prescribe and fit medically approved hearing aids, companies may offer over-the-counter products without consulting consumers. This can increase risks that consumers will improperly use the device and cause further harm to themselves.
To ensure your hearing device is legitimate, seek guidance from a medical professional.
When considering the purchase of an over-the-counter hearing device, remember these tips:
- Get a hearing screening and discuss your options with a medical professional.
- The FDA has not approved any over-the-counter hearing devices. Over-the-counter, direct-to-consumer hearing aids are not regulated and because of this, may work poorly or not at all and could be harmful.
- Research the seller with the Better Business Bureau.
- Be skeptical of online reviews and endorsements.
- Research the company’s purchasing policies related to returns and refunds carefully.
- Always remember: If it sounds too good to be true, it probably is.
File a Complaint:
If you have a similar report please contact the Iowa Attorney General’s Consumer Protection Division at email@example.com or 515-281-5926 (in Des Moines area) or 888-777-4590 (outside the metro area); or through our online complaint form.