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.
This article takes a comprehensive look at PSAPs. We’ve obtained input from several experts on this topic who discuss everything you need to know so you can determine if this is right for you.
Keep in mind that this article is not intended as medical advice. Before you purchase a PSAP, talk to your medical advisor or a board-certified audiologist first.
PSAPs have been around for a very long time, according to Alycia Anzalone, who has a master’s degree in communication disorders; and is an audiologist and trainer for the western division of Connect Hearing Inc. in Naperville, Illinois.
However, they are not considered a solution for hearing loss because they don’t meet the FDA criteria of a medical device, she noted.
“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,” Anzalone explained.
These devices are not customized for the individual wearer, added Anzalone, further noting that PSAPs 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.
Personal sound amplifiers have been offered for decades as an amplification solution, said Scot Frink, a Doctor of Audiology and co-owner of the Salem Audiology Clinic in Salem, Oregon.
“The FDA created this classification for devices not meant to correct hearing loss but for use in other areas, although persons with hearing loss do frequently attempt to use them instead of hearing aids, particularly due to their lower cost,” Dr. Frink said.
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, Dr. Frink added.
“So, some PSAPs are virtually hearing aids and consumers attempt to use them in this manner, but they are not allowed to be advertised as such,” Dr. Frink explained. “Hearing aids are required to be fit by licensed practitioners, hearing instrument specialists and audiologists, as delineated in individual state laws, but there are no other specific rules as to how PSAPs are distributed.”
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 Pacific Hearing & Balance, Inc. 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.
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.
Other than the regulations on how they are advertised or distributed, PSAPs and hearing aids are very similar, according to Dr. Frink.
A major difference is that hearing aids are professionally fit devices, whereas PSAPs are generally do-it-yourself instruments, he explained.
“Cost-wise, PSAPs are usually less expensive for many reasons, not all of them good ones,” Dr. Frink noted. “First, the devices themselves are more rudimentary, often using 1980’s analog technology, although some can be quite sophisticated.”
Hearing aids, by contrast, are highly specialized and computerized devices, most of them the equivalent of dual-core Pentium computers that have been reduced in size to fit on or in someone's ears.
“The real value of hearing aids, however, is the involvement and guidance of the professional in the equation,” Dr. Frink said. “Many lay people assume that improving hearing relies solely on the device, while the reality is that it's more akin to physical therapy and counseling.”
Every hearing loss is very different, and all patients react differently to amplification based on their hearing loss configuration, medical pathology, and life experience.
“You can fit ten people with the same hearing loss with the exact same hearing aids and get very different results for every person,” Dr. Frink noted. “This is because the neurological damage that occurs with hearing loss can affect very different pathways in each individual.”
Thus, the device they use needs to be customized to their individual perceptions of sounds, which also changes over time as their hearing is being rehabilitated.
“What seems ‘loud’ on the first day sounds ‘normal’ later,” Dr. Frink said. “By contrast, PSAPs, which aren't intended for persons with hearing loss by FDA definition, are severely limited in their abilities to be adjusted and customized to the user’s needs.”
The Conejo Hearing Center in Southern California has been receiving many calls asking about amplification hearing devices and systems, said Ann Castle, the center’s operation’s manager who’s in charge of marketing and communications.
“These products have been very misleading in their claims and must never be confused with hearing devices which are also medical devices,” Castle said.
Amplification is just that; a device that makes sounds louder.
“It’s like sitting in front of a TV and turning up the volume,” Castle noted. “That’s it. It’s a one-size-fits-all.”
Hearing devices, on the other hand, are specifically designed to be programmed to your unique hearing needs according to your audiogram and tympanogram, as well as your lifestyle with additional technology for the various environmental situations.
“If you have any level of hearing loss, it is best to consult with an audiologist in order to find out what is needed for you,” Castle advised.
If the FDA rule is followed, then they are most useful when someone with normal hearing wants to improve their ability to hear, according to Dr. Frink.
If used "off-label" for persons with hearing loss, they provide an inexpensive solution for people with no more than a mild degree of impairment.
“They can prove useful in cases when a person is in hospice, or otherwise the investment in hearing aids would prove cost-prohibitive, but benefits would be very limited with more degree of hearing loss or for people with more demanding communication needs,” Dr. Frink explained.
They can be of use to people in professional situations, not for their own use but when they encounter a person that has difficulty with hearing and needs some short-term assistance, such as a physician meeting with a patient or a lawyer meeting with a client, he added.
“PSAPs can provide some short-term assistance, but if the person truly has hearing loss they should then be referred to an audiologist to have a clinical diagnosis of it and to obtain long-term treatment, whether it be via medical, surgery, or professionally-fit hearing aids,” Dr. Frink advised.
Dr. Frazer added: “If you don’t have the money for traditional hearing aids, PSAPs are better than nothing.”
They are not precisely programmed to match an individual’s hearing loss so they can hear optimally, Dr. Frazer said.
“Also, new hearing aids can wirelessly pick up phone calls hands-free using Bluetooth, also stream TV, iPad, music, movie theaters, live theaters, etc. to the hearing aids,” he said. “You can also use a remote microphone to hear from long distances like in religious services, classrooms and lectures. Inexpensive PSAPS and over-the-counters generally cannot.”
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.
According to Anzalone, the range of PSAPs on the market today can be anywhere from $20 to $500, and they can range from the basic volume amplifier to more advanced models compatible with smartphones.
“If someone feels they have a hearing loss it is strongly advised to have a hearing test,” Anzalone advised. “If there is a hearing loss present without medical concerns, a customized hearing aid is the only recommendation.”
She added: “I am not aware of any insurance that provides coverage for PSAPs.”
According to Dr. Frink, PSAPs range from cheap $20 mail-order devices to hundreds of dollars for more sophisticated instruments.
“There are some very limited devices that are less than $20 and use very old technology, all the way through true hearing aids that are being marketed as PSAPs in order to avoid application of FDA regulations and are much higher in cost but lack the benefit of a professional fitting,” Dr. Frink said.
“In general, you get what you paid for,” said Dr. Frink, further adding that his primary experience has been the use of what's called pocketalker, which is a headset with an amplifying stream.
He added that it’s important to make sure the PSAP you purchase has a reasonable return policy.
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, added Ellen Simon, a licensed audiologist and executive director of the HEAR Center in Pasadena, California.
The first step should always be an appointment with your audiologist, Simon recommended.
If you truly suspect hearing loss, assuming a PSAP will solve your problem can be dangerous, which is one reason why the new FDA goal of creating an over-the-counter class of instruments is extremely distressing, Dr. Fink said.
Hearing loss can have many causes, he noted, from earwax to damaged eardrums, bacterial infections to auditory tumors.
“It is first and foremost important to have the cause of the hearing loss diagnosed rather than assumed that a PSAP is the simple solution,” Dr. Fink advised.
He further hypothesized if you have chronic migraines, you can’t assume taking aspirin will fix the problem.
“If you have persistent stomach pain, do you assume it’s indigestion and just take Pepto Bismo? What if you actually have appendicitis?” Dr. Fink said. “You should have it diagnosed to rule out other causes that can be scary, and hearing loss is no different.”
He further emphasized that anyone suspecting hearing loss should first have it diagnosed by a licensed audiologist, and then use their guidance to find the appropriate treatment that addresses not just the symptoms – but the cause as well.
According to Anzalone, “ensure that you first have a hearing evaluation and that there are no medical concerns.”
“If there is not a hearing loss present and a PSAP is something you want to try out…make sure it doesn’t over amplify sounds,” Anzalone advised. “This could damage your hearing and cause a hearing loss. Keep in mind that the FDA does not regulate PSAPs so they can claim to improve hearing and are not held to the same safety regulations as hearing aids.”
In further advice, “check out what people who have used them say,” Dr. Frazer said. “Also, make sure you have a 30 to 45-day trial to make sure they work for you.”
Important features that a PSAP should have include good clear sound and the ability to reduce background noise if possible, Dr. Frazer said.
“Also, the ability to adjust volume for both ears, independently,” he added. “If you can adjust frequency response, so much the better.”
As far as maintenance for a PSAP is concerned, Dr. Frazer used the comparison of maintenance for a hearing aid.
“Wax is the worst enemy for hearing aids – 80% of hearing aid repairs are due to wax,” Dr. Frazer said. “Clean your ears frequently and your hearing aids daily.”
If you choose to wear a PSAP over a hearing aid, make sure it is in a controlled environment and that loud sounds will not be over-amplified, Anzalone advised.
“Ensure it does not over-amplify sounds that could potentially damage your hearing,” said Anzalone, adding that it’s important to follow the maintenance tips provided by the manufacturer.
As with any electronic device, “avoid exposure to moisture and dust – debris clogging it up,” Dr. Frink recommended.
Anzalone said it’s not her personal recommendation to use PSAPs.
“PSAPs are not FDA regulated, are not to be used to compensate for hearing loss and can potentially harm existing hearing,” Anzalone said.
If you are experiencing hearing difficulties, have your hearing tested by a hearing healthcare professional, she recommended.
“There are many affordable personalized hearing aid options that would be a safer and better option for your hearing needs,” Anzalone said.
While PSAPs can provide some assistance at improving hearing, they are very limited in their abilities and should also be limited in their application, Dr. Frink added.
“If you suspect you have hearing loss, it is best to seek out the assistance of someone trained in its diagnosis before wasting money on a product that, at best, is ineffective and at worse, allows you to ignore something that can potentially be dangerous,” Dr. Frink advised.
» For Further Reading: Which Hearing Aid Is the Best? A Comprehensive Buying Guide