What Is A Personal Sound Amplification Device?

If you’re considering buying a Personal Sound Amplification Product, it’s important to be aware of their intentions, how they work, related costs and what they can and cannot do.

PSAPs have been around for a very long time, however, they are not considered a solution for hearing loss because they don’t meet the FDA criteria of a medical device. PSAPs are not regulated by the FDA since they are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body.

These devices are not customized for the individual wearer, and range from a very basic amplifier to a slightly more advanced generalized product that can be adjusted with some smartphones. PSAPs are intended to amplify environmental sound for non-hearing impaired consumers, according to a guidance document distributed by the FDA that was issued in 2013.

They are intended to accentuate sounds in specific listening environments, rather than for everyday use in multiple listening situations. They are not intended to compensate for hearing impairment or to address listening situations that are typically associated with and indicative of hearing loss.

Since the general concept of a hearing aid and a PSAP is similar, the only distinction is that hearing aids are meant to correct hearing loss while PSAPs are not allowed to be advertised in this manner.

How Do PSAPs Function?

The same as a hearing aid, said Gregory J. Frazer, Ph.D., a Doctor of Audiology who has taught hearing aid courses for several universities and has dispensed hearing aids for more than four decades.

A microphone picks up the sound, the amplifier amplifies the sound, and the speaker delivers the sound to the ear, noted Dr. Frazer, owner of West Coast Hearing & Balance in Los Angeles, California.

“The sound coming to the ear is in analog form, and if the PSAP or hearing aid is digital, the analog sound will be converted to digital – and changes are made to frequency response, gain, compression, noise reduction, etc. – and then the sound is converted back to analog,” Dr. Frazer explained. “There is some distortion in the process, more in inexpensive devices.”

There are many different PSAPs on the market and they can range from just making sounds louder to having the ability to manually adjust basic features with smartphones, Anzalone said.

“They can make sounds louder and can possibly have adjustments to optimize hearing in certain situations,” she noted, further adding that they are not customized and are not intended to compensate for any type of hearing loss.

PSAPs are really just cheap hearing aids, in the sense that they amplify sound, Dr.  Frazer added.

“They cannot be programmed to match an individual’s hearing loss like hearing aids can,” he said.

PSAPs Are Not Intended to Treat Hearing Loss

Since by FDA definition they are not intended to treat hearing loss, their use would be solely for improving the ability of someone with normal hearing to hear better in specific situations, whether it is a hunter while hunting or a person at a sporting event, or bird watchers listening for specific calls, Dr. Frink said.

“PSAPs, however, have been repurposed for ‘off-label’ use by some to help deal with hearing loss, but generally are inappropriate for anyone with more than a mild degree of impairment,” Dr. Frink explained.

He added that the new FDA rule being developed and scheduled for release in 2019 or 2020 will address this, introducing a new class of devices known as “over-the-counter” hearing aids, a category that most PSAPs would technically fall into, and will be best suited for people with no more than a mild degree of impairment.

“Beyond that range, hearing loss gets much more complicated and PSAPs or over-the-counters will prove inadequate or will not function optimally in comparison to what a professionally-fit set of instruments would do,” Dr. Frink added.

Recommended Brands of PSAPs

The price range of PSAPs is big, Dr. Frazer said, but generally, they cost less than $300, and over-the-counters are generally around $150 to $200.

Brands that consumers can trust, he added, include The Bean by Etymotic Research, the Tweak by Ear Technology, and the CS50+ by Sound World Solutions.

CS50 by Sound World Solutions

Candidates for PSAPs

If you don’t have the money to buy hearing aids, a PSAP will help you to hear better, Dr. Frazer said.

“You won’t hear as well as custom fit hearing aids that are fit by an audiologist or hearing aid dispenser, because PSAPs are inexpensive, and inexpensive devices have unacceptable levels of equivalent input noise and total harmonic distortion based on ANSI standards for traditional hearing aids,” Dr. Frazer explained.

Also, “the inexpensive PSAPs and over-the-counters provide insufficient high-frequency amplification (speech clarity) and too much low-frequency amplification for moderate degrees of hearing losses relative to a prescriptive target,” Dr. Frazer added.

PSAPs may be appealing to the public for the highly advertised low prices and availability, Anzalone said.

“However, a basic level hearing aid can be just as affordable and readily available,” Anzalone noted. “With a hearing aid, you get a customized programmed instrument with a money back trial period and warranty that is regulated by the state and FDA. PSAPs are not for the use of treating hearing loss.”

All people considering the use of an amplification device should be evaluated by a licensed audiologist to determine the best product for them.

For more information on PSAPs or to take a free, quick, confidential, online hearing test in Los Angeles, please contact Pacific Hearing Inc., at (310) 909-0180.

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