The case against personal sound amplification devices
You may not be able to tell from the advertising, but that small electronic device they're selling on the internet to "amplify your hearing" may not be an FDA-approved medical device and, despite the manufacturer's claims, may actually hurt your hearing more than it helps.
Hearing aids are regulated by the FDA as medical devices intended to treat hearing impairment. Healthcare professionals fit a hearing aid only after careful evaluation and diagnosis of the condition of your hearing health.
Personal Sound Amplification Products (PSAP), on the other hand, do not require a medical diagnosis or professional fitting and can be purchased over the counter or on the internet. They are to your ears what drug store reading glasses are for your eyes - and their low cost makes them an attractive option to the investment of prescription hearing aids. Many PSAPs look like Bluetooth devices instead of hearing aids and can be programmed with a smart phone.
It may be tempting to purchase a PSAP if you suspect you have hearing loss; however, medical professionals caution against this practice. Most PSAPs are "one size fits all" and can be uncomfortable to wear. Although they amplify sound, they cannot be adjusted to distinguish between background noise and voices. While many states require a 30-day trial period for hearing aid purchases, no such law exists for PSAPs.
Most importantly, without evaluation by a hearing health professional, using a PSAP may mask a potentially dangerous health condition.
"If you suspect hearing loss, get your hearing evaluated by a health care professional," Eric Mann, M.D., Ph. D. deputy director of FDA's Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices, said.
That's because there are a variety of reasons for hearing loss. Those with conductive hearing loss may have an obstruction which can be removed, such as ear wax or a benign tumor, or inflammation from an infection which can often be successfully treated with antibiotics. Those with sensorineural hearing loss have sustained some damage to the middle ear and/or auditory nerve. Causes for this damage may range from prolonged or sudden exposure to loud noise levels, to complications from ototoxic medications, to trauma to the head - or simply old age. Only specialized testing by an audiologist can determine the cause and extent of the damage and which hearing aid and features, if any, will appropriately address the patient's lifestyle and hearing health.
If you suspect you have hearing loss visit your hearing healthcare professional. The audiologist will administer a hearing test which determines what type of hearing loss, if any, you have. Depending on your diagnosis you will either be referred to a doctor for treatment of your conductive hearing loss, or advised to invest in a pair of hearing aids. If you need hearing aids, you can usually request a trial period for a pair that has been programmed to address your specific hearing issues. During the trial period, your audiologist will tweak the instruments according to the information you provide at follow up visits. At the end of the trial period, you should be hearing better and comfortable using your hearing aids.
In what situations are PSAPs appropriate? These electronic devices are solely designed for recreational use. For example, they are good for hunters and bird watchers who want to amplify animal sounds in the forest, or for amplifying voices of thespians and lecturers for those attending the theatre or sitting in a large auditorium.
It's important for consumers to understand the difference between prescription hearing aids and PSAPs because some retailers are marketing PSAPs directly to the consumer, saying they are designed for "mild to moderate hearing loss." Others are marketing PSAPs as hearing aids, which is also a clear violation of the law.
By law, consumers must sign a waiver if they decide to purchase hearing aids without an examination by a medical doctor. Consumer groups and hearing health organizations, such as the American Speech-Language-Hearing Association (ASHA), the Academy of Doctors of Audiology and the International Hearing Society, have asked the FDA to investigate retailers who are incorrectly marketing products directly to consumers in order to circumvent FDA regulations.