Hearing Healthcare Impact of Over The Counter PSAP & Hearing Aids

[revised 10/15/17]


  • OTC PSAP-Over-The-Counter Personal Sound Amplification Product for mild hearing loss sold for years.
  • Like reading glasses for vision loss.
  • PSAP not classified as a medical device.
  • HAs-Hearing aids are classified as medical devices by FDA.
  • OTC HAs for mild hearing loss sold for years.
  • Science found 66% of OTC HAs were defective: too loud, static, distortion, speech in noise feature didn’t work (directional microphones).

OTC Product that Passed 2016 sound quality testing:

PSAP: Soundhawk (~$349/one; Store.soundhawk.com)

HA: Hansaton Base m2 (~$800/pair; Lloydhearingaid.com)

WORST OTC  Product that Failed 2016 sound quality testing:

HA MD Hearing Aid Pro

PSAP Williams Sound Pockettalker Ultra

PSAP Cyberscience Amplifier

PSAP Woodland Whisper

PSAP EarMachine app (all apps failed)

 “When it comes to purchasing a hearing device, the brand name is a more important decision than it is when purchasing your paper towels. After all, this device is going to be used for daily communication, and that’s a big deal!” Dr. Lindsey Banks, Au.D (2017)


  • The Over-The-Counter Hearing Aid Act of 2017 passed July, 2017 promising low cost HAs sold OTC for first time for mild HL (not factual).
  • 24 new HA manufacturers hit market September 18, 2017 selling wearable Behind-The-Ear OTC PSAP.
  • Legislators call new product category PSAP sold OTC for first time (not factual)
  • Within 3 years, HAs no longer classified as medical device.
  • New definition of HA = anything a mfg labels, claims, advertises or sells as a HA.
  • Then 24 new hearing aid manufacturers can repackage/new advertising for same PSAP as “new” HAs. Will they still be low cost?
  • American Consumer Institute calls The Over-The-Counter Hearing Aid Act of 2017 crony capitalism; government passing legislation to help their manufacturing buddies with no benefit to consumer.

PSAPs with directional microphones, Hearing Loop connect and compatible with certain HAs for better hearing speech in noise includes Bellman & Symfon ranked #2 on google PSAP search results before and after new PSAP/HA manufacturers hit market.

Hearing Health Protection

  1. If you’ve had your hearing tested before, know its mild, and don’t need medical treatment, OTC PSAP/HAs are a low cost option.
  2. Otherwise, get free hearing test offered by hearing clinics for hearing screening and short consultation. Do you need medical referral? Do you have mild hearing loss?
  3. If you can hear in both ears, you need a pair of HAs for best hearing health.
  4. Decide what product you want OTC PSAP/HA or Rx HA.
  5. If OTC PSAP/HAs, buyer beware given 66% defect rate in past. Be very careful which manufacturer you choose.
  6. Directional microphones are a must have feature; hearing loop or telecoil also good. Noise and feedback reduction are not must have.
  7. Return any PSAP/HAs that have bad sound quality. e.g. too loud, too much static, sounds distorted, can’t hear in background noise. Voices should sound louder from front if directional microphones are working.

Link to blog Low Cost Prescription Hearing Aids for Tinnitus & Hyperacusis

Jan’s Book Portfolio

Jan L. Mayes MSc writes horror fiction and non-fiction, and is an international Eric Hoffer Award winning author, blogger and audiologist specializing in noise, tinnitus-hyperacusis, hearing health education and plotting murders. Her writing has been featured at Tinnitus Today, Communique, silencity.com and The Horror News Daily.

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  1. Smith C, Wilber LA, Cavitt K. (2016). PSAPs vs Hearing Aids: An Electroacoustic Analysis of Performance and Fitting Capabilities. Hearing Review. 2016;23(7):18. http://www.hearingreview.com/2016/06/psaps-vs-hearing-aids-electroacoustic-analysis-performance-fitting-capabilities/
  2. Pociask, S. (2017). The myth of OTC hearing aids. The Hill. Published online July 10, 2017. http://thehill.com/blogs/congress-blog/healthcare/341257-the-myth-of-otc-hearing-aids#.Wccrv-2AnWM.facebook
  3. Banks, L. (2017). The Top 6 Most Reputable Hearing Aid Brands. Everyday Hearing. Online May 30, 2017. https://www.everydayhearing.com/hearing-aids/articles/top-6-most-reputable-hearing-aid-brands/
  4. Published on March 21, 2017. Over-the-Counter Hearing Aid Act of 2017 Introduced in Congress. The Hearing Review. http://www.hearingreview.com/2017/03/counter-hearing-aid-act-2017-introduced-congress/
  5. https://www.health.harvard.edu/staying-healthy/sound-amplification-device-may-be-a-cheaper-hearing-aid-choice

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