Personal sound amplification product

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Personal Sound Amplification Products, also known as "Personal Sound Amplification Devices," or by the acronym PSAP, are defined by the U.S. Food and Drug Administration as wearable electronic products that are intended to amplify sounds for people who are not Deaf or Hard of Hearing. They are not hearing aids, which the FDA describes as intended to compensate for hearing loss. According to Dr. Mann of the FDA, choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing. [1]

Contents

Differences

Both PSAPs and hearing aids are small electronic devices that fit into the ear and amplify sound. PSAPs are mostly off-the-shelf amplifiers for people with normal hearing who need a little boost in volume in certain settings (such as hunting and bird watching). Hearing aids contain a much higher level of technology prescribed to treat a diagnosed hearing loss. [2] PSAPs are not regulated under the Food, Drug and Cosmetic Act because they are not intended to treat, diagnose or cure hearing impairment and do not alter the structure or function of the body. As a result, there is no regulatory classification, product code or definition for these products. However, the FDA does regulate PSAPs under certain provisions of the Radiation Control for Health and Safety Act of 1968, covering electronic products such as sound amplification equipment that emits sonic vibrations. [3]

PSAPs

Because they do not require a medical prescription and professional fitting, PSAPs have been described as the audio version of reading glasses. [4] As such, PSAPs are suggested for use by hunters listening for prey, for bird watching, assistance hearing distant conversations or performances and amplifying the sound of a television in a quiet room, for example. [3] Of note, even reading glasses are regulated under the FDA. [5]

Various models of PSAPs from a variety of manufacturers vary in price, performance, weight, user experience and the software algorithms to enhance and tailor hearing. While some models simply amplify sound, others are more sophisticated designs, providing directional microphones and customizable equalization of the audio signal to clear up ambient or extraneous noise. [6]

PSAPs have grown in popularity among people with hearing impairment, in part because they are less expensive than custom hearing aids, [7] although apathy, vanity and difficulty scheduling appointments with audiologists also have been cited as reasons for low hearing aid adoption. [8] Because they do not require medical examination and fitting, PSAPs range from as little as 50 to several hundred dollars in price, while custom hearing aids cost about $1400 on average [9] and are not covered by Medicare and many insurance plans. [4]

According to the National Institute of Deafness and Other Communication Diseases, of the 36 million Americans who might benefit from a hearing aid, only about 20 percent actually use one. [4] However, a 2010 survey indicates that fewer than 18 percent of PSAPs were used as a substitute for custom hearing aids and concludes that the majority of PSAP users would have lived with their hearing loss because of the higher price of hearing aids. [9]

Many PSAPs are sold direct to the consumer through online stores, at pharmacies and through many drugstore and retail store chains.

PSAP Amplifiers

PSAP amplifiers are usually small simple devices. They amplify sounds and deliver the result to the ear(s) of the user. The main components are a microphone, amplifier, speaker, volume controller and power source.

The microphone captures the sound (pressure) waves and converts them to an electric signal. The amplifier (an electronic circuit) increases the amplitude of the electric signal using a power source (battery). The speaker converts the amplified electric signal back into a sound wave. The volume (gain) control is used to adjust the amount of amplification applied to the electric signal and thus, indirectly, controls the sound volume.

The devices vary in size from small boxes (with an earpiece attached) worn around the neck or hung off of a belt - down to - a tiny encapsulated device that fits inside the ear canal. These smaller devices look like hearing aids but are far simpler and do not correct hearing loss.

Related Research Articles

This is a glossary of medical terms related to communication disorders which are psychological or medical conditions that could have the potential to affect the ways in which individuals can hear, listen, understand, speak and respond to others.

<span class="mw-page-title-main">Headphones</span> Device placed near the ears that plays sound

Headphones are a pair of small loudspeaker drivers worn on or around the head over a user's ears. They are electroacoustic transducers, which convert an electrical signal to a corresponding sound. Headphones let a single user listen to an audio source privately, in contrast to a loudspeaker, which emits sound into the open air for anyone nearby to hear. Headphones are also known as earphones or, colloquially, cans. Circumaural and supra-aural headphones use a band over the top of the head to hold the speakers in place. Another type, known as earbuds or earpieces consist of individual units that plug into the user's ear canal. A third type are bone conduction headphones, which typically wrap around the back of the head and rest in front of the ear canal, leaving the ear canal open. In the context of telecommunication, a headset is a combination of headphone and microphone.

<span class="mw-page-title-main">Instrument amplifier</span> Speaker and anplifier for use with musical instruments

An instrument amplifier is an electronic device that converts the often barely audible or purely electronic signal of a musical instrument into a larger electronic signal to feed to a loudspeaker. An instrument amplifier is used with musical instruments such as an electric guitar, an electric bass, electric organ, synthesizers and drum machine to convert the signal from the pickup or other sound source into an electronic signal that has enough power, due to being routed through a power amplifier, capable of driving one or more loudspeaker that can be heard by the performers and audience.

<span class="mw-page-title-main">Hearing aid</span> Electroacoustic device

A hearing aid is a device designed to improve hearing by making sound audible to a person with hearing loss. Hearing aids are classified as medical devices in most countries, and regulated by the respective regulations. Small audio amplifiers such as personal sound amplification products (PSAPs) or other plain sound reinforcing systems cannot be sold as "hearing aids".

Bone conduction is the conduction of sound to the inner ear primarily through the bones of the skull, allowing the hearer to perceive audio content without blocking the ear canal. Bone conduction transmission occurs constantly as sound waves vibrate bone, specifically the bones in the skull, although it is hard for the average individual to distinguish sound being conveyed through the bone as opposed to the sound being conveyed through the air via the ear canal. Intentional transmission of sound through bone can be used with individuals with normal hearing — as with bone-conduction headphones — or as a treatment option for certain types of hearing impairment. Bone generally conveys lower-frequency sounds better than higher frequency sounds.

<span class="mw-page-title-main">Sound reinforcement system</span> Amplified sound system for public events

A sound reinforcement system is the combination of microphones, signal processors, amplifiers, and loudspeakers in enclosures all controlled by a mixing console that makes live or pre-recorded sounds louder and may also distribute those sounds to a larger or more distant audience. In many situations, a sound reinforcement system is also used to enhance or alter the sound of the sources on the stage, typically by using electronic effects, such as reverb, as opposed to simply amplifying the sources unaltered.

<span class="mw-page-title-main">Bone-anchored hearing aid</span>

A bone-anchored hearing aid (BAHA) is a type of hearing aid based on bone conduction. It is primarily suited for people who have conductive hearing losses, unilateral hearing loss, single-sided deafness and people with mixed hearing losses who cannot otherwise wear 'in the ear' or 'behind the ear' hearing aids. They are more expensive than conventional hearing aids, and their placement involves invasive surgery which carries a risk of complications, although when complications do occur, they are usually minor.

<span class="mw-page-title-main">Carbon microphone</span> Microphone design

The carbon microphone, also known as carbon button microphone, button microphone, or carbon transmitter, is a type of microphone, a transducer that converts sound to an electrical audio signal. It consists of two metal plates separated by granules of carbon. One plate is very thin and faces toward the speaking person, acting as a diaphragm. Sound waves striking the diaphragm cause it to vibrate, exerting a varying pressure on the granules, which in turn changes the electrical resistance between the plates. Higher pressure lowers the resistance as the granules are pushed closer together. A steady direct current is passed between the plates through the granules. The varying resistance results in a modulation of the current, creating a varying electric current that reproduces the varying pressure of the sound wave. In telephony, this undulating current is directly passed through the telephone wires to the central office. In public address systems it is amplified by an audio amplifier. The frequency response of most carbon microphones, however, are limited to a narrow range, and the device produces significant electrical noise.

Adaptive feedback cancellation is a common method of cancelling audio feedback in a variety of electro-acoustic systems such as digital hearing aids. The time varying acoustic feedback leakage paths can only be eliminated with adaptive feedback cancellation. When an electro-acoustic system with an adaptive feedback canceller is presented with a correlated input signal, a recurrent distortion artifact, entrainment is generated. There is a difference between the system identification and feedback cancellation.

A contralateral routing of signals (CROS) hearing aid is a type of hearing aid that is used to treat a condition in which the patient has no usable hearing in one ear and minimal hearing loss or normal hearing in the other ear. This is referred to as single sided deafness.

Electric acoustic stimulation (EAS) is the use of a hearing aid and a cochlear implant technology together in the same ear. EAS is intended for people with high-frequency hearing loss, who can hear low-pitched sounds but not high-pitched ones. The hearing aid acoustically amplifies low-frequency sounds, while the cochlear implant electrically stimulates the middle- and high-frequency sounds. The inner ear then processes the acoustic and electric stimuli simultaneously, to give the patient the perception of sound.

An extended-wear hearing aid is a type of hearing aid that is placed deep in the ear canal and can be worn for several months at a time without removal. This type of hearing aid is primarily suited for people who have mild to moderately severe hearing loss. This new hearing aid concept was invented by Adnan Shennib, founder of InSound Medical, Inc.

<span class="mw-page-title-main">Assistive listening device</span>

An assistive listening device (ALD) is part of a system used to improve hearing ability for people in a variety of situations where they are unable to distinguish speech in noisy environments. Often, in a noisy or crowded room it is almost impossible for an individual who is hard of hearing to distinguish one voice among many. This is often exacerbated by the effect of room acoustics on the quality of perceived speech. Hearing aids are able to amplify and process these sounds, and improve the speech to noise ratio. However, if the sound is too distorted by the time it reaches the listener, even the best hearing aids will struggle to unscramble the signal. Assistive listening devices offer a more adaptive alternative to hearing aids, but can be more complex and cumbersome.

<span class="mw-page-title-main">Miracle-Ear</span>

Miracle-Ear, Inc. is a hearing aid company consisting of a network of franchised and corporately-owned retail locations. The company is a subsidiary of Amplifon, the worldwide distributor of hearing aids based in Italy. Miracle-Ear's U.S. headquarters are located in Minneapolis, Minnesota. As of 2023 it has more than 1,500 locations in the United States, and it is the best-known hearing aid brand in the U.S. In 2014, the company added several locations in Canada, with plans to open more Canadian outlets. According to the company, Miracle-Ear outlets offer free hearing tests and consultations, and the hearing aids include a risk-free 30-day trial period plus service, warranty, and lifetime after-care.

<span class="mw-page-title-main">History of hearing aids</span>

The first hearing aid was created in the 17th century. The movement toward modern hearing aids began with the creation of the telephone, and the first electric hearing aid was created in 1898. By the late 20th century, the digital hearing aid was distributed to the public commercially. Some of the first hearing aids were external hearing aids. External hearing aids directed sounds in front of the ear and blocked all other noises. The apparatus would fit behind or in the ear.

SoundBite Hearing System is a non-surgical bone conduction prosthetic device that transmits sound via the teeth. It is an alternative to surgical bone conduction prosthetic devices, which require surgical implantation into the skull to conduct sound.

<span class="mw-page-title-main">Real ear measurement</span>

Real ear measurement is the measurement of sound pressure level in a patient's ear canal developed when a hearing aid is worn. It is measured with the use of a silicone probe tube inserted in the canal connected to a microphone outside the ear and is done to verify that the hearing aid is providing suitable amplification for a patient's hearing loss. The American Speech–Language–Hearing Association (ASHA) and American Academy of Audiology (AAA) recommend real ear measures as the preferred method of verifying the performance of hearing aids. Used by audiologists and other hearing healthcare practitioners in the process of hearing aid fitting, real ear measures are the most reliable and efficient method for assessing the benefit provided by the amplification. Measurement of the sound level in the ear canal allows the clinician to make informed judgements on audibility of sound in the ear and the effectiveness of hearing aid treatment.

<span class="mw-page-title-main">TV Ears</span>

TV Ears is an American, privately held audio technology company that specializes in voice clarifying television products for the hearing impaired. It was founded in April 1998 by George Dennis. They are located in Spring Valley, California, where they house the North American distribution center, support, and sales teams, while employing approximately 50 people. TV Ears serves hearing impaired customers throughout the world, with their predominant markets being in the United States, Canada, and Europe.

Treatment depends on the specific cause if known as well as the extent, type, and configuration of the hearing loss. Most hearing loss results from age and noise, is progressive, and irreversible. There are currently no approved or recommended treatments to restore hearing; it is commonly managed through using hearing aids. A few specific types of hearing loss are amenable to surgical treatment. In other cases, treatment involves addressing underlying pathologies, but any hearing loss incurred may be permanent.

<span class="mw-page-title-main">Over-the-Counter Hearing Aid Act of 2017</span>

The Over-the-Counter Hearing Aid Act of 2017 was a law passed by the 115th United States Congress as a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the Food and Drug Administration (FDA) available directly to consumers without involvement from a licensed professional. Regulations for this new class of hearing aid are expected to be released by the end of 2020.

References

  1. Mann, Eric A., M.D., Ph.D., “Hearing Aids and Personal Sound Amplifiers: Know the Difference”, U.S. Food and Drug Administration Consumer Updates website, Oct. 20, 2009. Retrieved 2013-05-23.
  2. Neil DiSarno, an audiologist and chief staff officer of audiology at the American Speech-Language-Hearing Association in Rockville, Md. “Pros and Cons of Inexpensive Hearing Aids Called PSAPs”
  3. 1 2 Mann, “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products”, U.S. Food and Drug Administration website, Feb. 25, 2009. Retrieved 2013-05-23.
  4. 1 2 3 Beck, Melinda, “Testing, Testing...Can You Hear Better Now?”, The Wall Street Journal, Sept. 10. 2012. Retrieved 2013-05-23.
  5. "Reading Glasses — Types, Styles, and Much More!". 14 October 2013.
  6. Beck, Melinda, “Getting an Earful: Testing A Tiny, Pricey Hearing Aid”, The Wall Street Journal, Jan. 29, 2008. Retrieved 2013-05-23.
  7. Strom, Karl, “The PSAP Dilemma” Archived 2013-06-24 at archive.today , The Hearing Review, June 2010. Retrieved 2013-05-29.,
  8. Ramachandran, Virginia, Stach, Brad, “Just Making Hearing Aid Less Expensive Doesn't Encourage Earlier Use” Archived 2013-06-24 at archive.today , The Hearing Review, May 2011. Retrieved 2013-05-28.
  9. 1 2 Kochkin, Sergei, Ph.D., “MarkeTrak VIII: Utilization of PSAPs and Direct-Mail Hearing Aids by People with Hearing Impairment” [ permanent dead link ], The Hearing Review, June 2010; Volume 17, Number 6. Retrieved 2013-05-23.