Discussion #2: OTC Hearing Aids

The President recently signed into law a bill that allows individuals with “mild-moderate” hearing loss to purchase

hearing aids

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without being seen by a hearing health care provider. While the law limits purchase for those under the age of 18, it will be difficult to police. What are your thoughts?

replay to these student

Student 1:

According to Midey et al. (2022), 30 million Americans have bilateral hearing loss, but only about 30% of those over 70 who could benefit from hearing aids use them. Over the counter hearing aids recently became available for people over the age of 18 with mild to moderate hearing loss (De Sousa et al. 2022). There are some benefits to this. They are cheaper, they are easier to get, and you do not have to have a hearing evaluation to get them. More people with hearing loss may decide to try hearing aids because of the convenience and cost, but I believe that a hearing evaluation should still be completed.

There are many drawbacks to over-the-counter hearing aids. One is that they do not come with the one-on-one instruction and adjustment that you get when purchasing hearing aids through an audiologist. You must fit and program them yourself. Another drawback to OTC hearing aids is that you can get them without first having a hearing evaluation. This could lead to serious problems going untreated. A third problem that may occur is that community Pharmacists will be expected to answer many questions about the hearing aids (Midey et al. 2022). If the pharmacist does not have proper knowledge or education about the hearing aids, people will be left with unanswered questions. Another drawback is that there are not yet enough studies to prove the effectiveness of OTC hearing aids (Sousa et al. 2022). This will come with time, but for now it is unknown if these devices are as effective as those available from hearing health providers.

In my opinion, OTC hearing aids are a good option, OTC hearing aids after having a hearing screening and a prescription are a better option, and hearing aids from a hearing health professional with ongoing care are the best option.


De Sousa, K., Manchaiah, V., Moore, D., Graham, M. Swanepoel, D. (2022, December, 13). Effectiveness of an over-the-counter self-fitting hearing aid compared to an audiologist-fitted hearing aid: A randomized clinical trial. MedRxiv. doi: https://doi.org/10.1101/2022.12.12.22283331

Midey, E., Gaggini, A., Mormer, E., & Berenbrok, L. (2022, November 12). National survey of pharmacist awareness, interest, and readiness for over-the-counter hearing aids. Pharmacy. 2022; 10(6):150. https://doi.org/10.3390/pharmacy10060150

Student 2:

This does not seem like a very smart idea. There are many reasons that someone would need to see a hearing health care provider. For example, the person may not know the degree of their hearing loss, therefore how do they know that they only have mild-moderate hearing loss? Also, it can be beneficial to have the professional fit the hearing aid and then observe how the product is working for the individual (Hernandez & Keck, 2022).

This law will probably help older adults who just wait to get hearing aids even though they know that they need them. However, I am sure that somehow people who are under the age of 18 will still find a way to get hearing aids without seeing a hearing healthcare provider. For example, while the over-the-counter hearing aid may not fit a 4-year-old, it is possible that it could fit a 16-year-old. Therefore a parent could just purchase these without seeing the audiologist and give them to their child.

The individuals who decide not to seek a hearing healthcare provider first will also miss out on the opportunities to compare and contrast brands or to describe the features that they want in a hearing aid (Hernandez & Keck, 2022). Audiologists work with hearing aids every day. They would need to have some idea of what hearing aid brands work better for the specific wants and needs of a person. They would also know more about the features and be able to answer questions that the client has. Otherwise, it is up to the client to do the research on their own (Hernandez & Keck, 2022). There would need to be extensive research done in order to get the brand and features that would fit the individual’s needs best.


Hernandez, J., & Keck, N. (2022, October 17). What to know now that hearing aids are available over the counter. NPR. Retrieved January 29, 2023, from


Why Use Assistive
Listening Devices?
• Why aren’t hearing aids
• What do hearing aids do?
• What do ALDs do?
Background Noise/Aspects of
Sound for Communication
• Dimensions
o Frequency
o Loudness
• Impact on Speech
o Distance
o Signal to Noise Ratio
o Reverberation
What are Assistive
Listening Devices?
According to the NIDCD (National Institute on
Deafness and Other Communication Disorders)
• Any device that helps a person with hearing loss or a
voice, speech or language disorder to
• Devices that help a person to hear and understand
what is being said more clearly, or to express their
thoughts more easily
Types of Assistive Devices
• Assistive Listening Devices (ALDs), help amplify the
sounds you want to hear, especially when there is a
lot of background noise.
• Augmentative and alternative communication
(AAC) devices help people with communication
disorders express themselves
• Alerting devices connect to a doorbell, telephone,
or alarm that emit a loud sound or blinking light to let
someone with HL know an event is taking place.
Assistive Listening
• Designed for large facilities such as classrooms,
theaters, places of worship, and airports
o Large Facilities include hearing loop systems, frequency-modulated (FM)
systems, and infrared systems.
• Personal use in small settings and for one-on-one
• All can be used with or without HAs or CIs.
Hearing Loop (Induction
Loop) Systems
• Use electromagnetic energy to transmit sound.
• Involves 4 parts:
o A sound source such as public address system, microphone, or
home TV or telephone
o An amplifier
o A thin loop of wire that encircles a room or branches out beneath
o A receiver worn in the ears or as a headset
True or False?
Hearing Loops
• You can leave the room and still hear the
• This system can be used indoors or outdoors.
• You must have a receiver to use this system.
• You must have a hearing aid to use this system.
• You can use induction loops in many rooms in a
• I can use my loop receiver with your loop transmitter.
Induction Loop
Low equipment cost after installation
Easy operation
Induction receivers are compatible with ALL loop
• Unobtrusive with telecoil HA
• Convenience (user and venue)
• Cosmetics (user)

Induction Loop

Installation costs may be high
Installation may not be possible in historic buildings
Can’t assume everyone will have a telecoil
Susceptible to electrical interference and spillover
Must sit around looped area
May be dead areas within loop
FM Systems
• Uses radio waves
o The FM band 72-76 MHz or 216-217 MHz
o Transmitter
o Receiver
True or False?
FM Systems
• You can leave the room and still hear the
• This system can be used indoors or outdoors.
• You must have a receiver to use this system.
• You must have a hearing aid to use this system.
• You can use induction loops in many rooms in a
• I can use my FM receiver with your lFM transmitter.
FM Advantages

Very portable
Very easy to set up and use
Offers great flexibility of movement
Used indoors or outdoors
Appropriate for mild to profound hearing losses
Receiver can be covered or put in pocket
No fluctuation in strength of signal
FM Disadvantages
• Receivers are required for everyone
• Receivers vary in quality and durability
• Potential for outside interference
o 72-76 MHz bandwidth allotted by the FCC
o Police band, construction, walkie talkies, pagers
• Receivers and transmitters must be on the same
• There must be 1 free channel between systems used
in close proximity
• Uses infrared light
• Transmitter-emitter panel
o Like the infrared diode on a
remote control
o Emits signal in 60 degree cone-like
a flashlight
• Receiver
o Like the infrared receiver area
on a TV or DVD player
• TV headphones
True or False?
• You can leave the room and still hear the
• This system can be used indoors or outdoors.
• You must have a receiver to use this system.
• You must have a hearing aid to use this system.
• You can use induction loops in many rooms in a
• I can use my infrared receiver with your infrared
Infrared Advantages
• Compatibility: 95 kHz is industry standard
o Home receivers can be used with public transmitters
o 250 kHz of high intensity lighting

No spillover means security
Can be used in adjacent rooms
Widest bandwidth and best sound reproduction
Appropriate for mild to moderate/severe loss
Not affected by radio transmission
Infrared Disadvantages

Receivers required for everyone
Must have direct line of sight
Can’t cover the receiver or put in pocket
Indoor or evening use only
High intensity or fluorescent lights cause interference
Large areas require multiple emitter panels
Quality varies with company
Hearing Aids: Microphone vs T-Coil
Not all hearing aids have T-Coils
Proximity is important
Commonly found in landline telephones and
• Susceptible to electromagnetic interference

• Landline and Cell Phones
o There are landline and cellphones that are compatible with
hearing aids and CIs. This typically done by having a
telecoil in the phone.
• Captioned Phones
o Specific telephones that use
advanced technology and captioning
agents to provide written captions
of what callers say on a large,
easy to read screen.
• Latest innovation among hearing aid users
• Wireless hearing aids can use compatible ALD or
intermediary devices
o Streamer, neckloop, headset, microphone
• Apple patented Bluetooth Connectivity
o Made for iPhone
Wireless benefits
• Sound quality
• Localization
• Convenience
• Connectivity
Wireless Disadvantages
• Cost
• Cosmetics/Size
• Require set up for pairing with Bluetooth Devices
Alerting Devices
• Sound, Light, Vibrations, or a combination
• Visual alert signalers in household devices such as
doorbells, phones, baby monitors, etc.
• Hearables
• Hearing aids
Higher price point
Mass Appeal
• Consumer
o Off-the-shelf
o Mass Appeal
o Lower Price Point
o Immediate
The Spectrum of
• Made for iPhone Hearing Aids
• Amplification Apps
What is a PSAP?
• “Personal Sound Amplification Product”
• Intended to amplify environmental sounds for nonhearing impaired users
• Single environment only
• Environments in which normal-hearing individuals would have trouble
o Bird-watching/listening
o Hunting
o Listening at great distances
• Not currently regulated by the FDA
• Range in price from $1 to $400+
What is a Hearable?
• Multi-purpose wireless earbuds, with features

Voice/music streaming
Built-in music & data storage
Touch/voice/gesture control
Health-tracking functionality
Sound enhancement/”augmented reality”
Noise protection
• Intended to interface with other devices (computer,
smart phone, tablet)
• Not regulated by the FDA
• Range in price from $200-$600
• Examples:
o Bragi Dash: https://www.bragi.com/thedashpro/customize/
o Moto Hint: http://www.amazon.com/Moto-Hint-Mono-Bluetooth-Headset/
o Here Active Listening: http://www.hereplus.me/pages/product/
Comparing Hearables,
PSAPs, & Hearing Aids
• Hearables & PSAPs
Amplifies/alters sound
Varying features with price
Can be purchased without audiology consultation
SHOULD NOT be marked as treatment for hearing loss
• Hearing Aids
Amplifies/alters sound
Varying features with price
Can be purchased without audiologist consultation
Can be marked as treatment for hearing loss
FDA Guidance
• PSAP/Hearable
o “PSAPs are not intended to amplify environmental sound for non-hearing
impaired consumers.”
o “They are intended to accentuate sounds in specific listening
environments, rather than for everyday use in multiple environments
o Should not:
• Intend to compensate for impaired hearing
• Suggest device is a hearing aid alternative
• Hearing aid
o Requires adequate and appropriate labeling
o Medical Clearance/waiver
o User instructional brochure
Problems with Hearables
• Due to lack of formal regulation, the market
demonstrates extreme variability in quality,
performance, and pricing.
• Inconsistent marketing to an already vulnerable
consumer population leads to increased confusion
regarding these devices and their appropriateness.
• Major corporations soon to enter the PSAP/Hearable
o Starkey/Bragi partnership
o Google
o Samsung
o Apple

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