In the past few years, many organizations have begun to offer Hearing Aids and/or Personal Sound Amplification Products (PSAP’s) online. The introduction of hearing aid sales through the internet has raised many concerns and questions. Of critical importance is that these devices must adhere to the current U. S. Food and Drug Administration (FDA) regulations as well as to state requirements for the sale and dispensing of hearing aids. Consumers must understand their rights and also be familiar with the laws that are in place to protect them.
What is the difference between hearing aids and personal amplifiers?
Hearing aids are designed to compensate for a defined hearing loss. PSAP’s are designed to assist individuals without hearing loss to magnify environmental sounds.
- Hearing aids are considered medical devices and are regulated by FDA. They must comply with labeling requirements, may be purchased by a consumer only with a medical evaluation (or waiver), and may be subject to premarket review (testing at various clinics around the US prior to the ability to sell the devices).
- PSAP’s are not regulated by the FDA because they are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body. Because they are not defined as medical devices by the FDA, there is no regulatory classification, product code, or definition for these products.
- Hearing aids are dispensed by an Audiologist who has the ability to custom fit, design, and adjust these sophisticated devices for an individual’s hearing loss and listening needs. Personal sound amplifiers are not adjusted for you specifically and may work only in a few instances by providing simple amplification of sound.
- Hearing aids are sophisticated devices that are programmed to fit an individual’s hearing loss and are adjusted based on the needs of the individual wearing them. PSAP’s provide general overall amplification of all sounds in the environment and, generally, are not adaptable to an individual’s needs.
Consumers should be aware that some advertising and marketing ploys may misrepresent personal sound amplifiers as hearing aids.
Regulations for Internet Sales of Hearing Aids
Some states specifically or generally prohibit the sale of hearing instruments through the mail or online. Most of the top hearing aid manufacturers also prohibit the direct sale of their products to consumers without the involvement of a hearing healthcare professional. Without the assistance of a professional in the fitting of amplification, patient safety may be in jeopardy. For example, certain types of hearing loss can be caused by infections, genetic diseases, tumors, strokes, toxins, or other medical conditions.
It is important to receive a medical evaluation prior to the purchase of hearing aids. Patient’s may waive this right, but it is not in their best interest. Some sites merely require the purchaser to check a box to waive the medical evaluation. This can potentially be in conflict with one of the FDA requirements which states that the hearing aid dispenser may afford the prospective user an opportunity to waive the medical evaluation provided that the hearing aid dispenser:
- Informs the prospective user that the exercise of the waiver is not in the user’s best health interest.
- Does not in any way actively encourage the prospective user to waive such a medical evaluation; and
- Affords the prospective user the opportunity to “sign” a detailed statement of waiver.
The online sale of hearing aids also does not afford the consumer the access to a licensed hearing professional to appropriately fit a hearing aid. When fitted with hearing aids, there is an adjustment process that patients go through over a period of time. It is important to first have the hearing aid appropriately fit according to your hearing loss. It is equally as important to be able to return to the place of purchase for adjustments to the hearing aids and assistance with auditory rehabilitation and counseling to ensure appropriate fit and use of the hearing aids.
Online hearing tests
Prior to purchasing hearing aids, Audiologists obtain a thorough medical history about current and past medical conditions, particularly as it relates to your ears and hearing. There are many physical conditions and medications that can impact your hearing. Additionally, if you are experiencing tinnitus (“ringing in the ears”), balance problems such as dizziness or vertigo, or noise induced hearing loss, the Audiologist will address these with you in a face-to-face evaluation. At Advantage Audiology we can provide direct referrals to our ear, nose, and throat physicians who will provide complete work-ups for medically related hearing loss. This cannot happen through an online hearing test.
As part of the overall hearing evaluation, it is mandatory that the Audiologist assess your ears with an otoscope (a lighted, magnifying device) to determine if obstructions like ear wax are present in the ear canal. This is not possible in a self-examination at home. In addition, the Audiologist can help identify other potential medical problems such as drainage, bleeding, or rashes or bumps in and around the ear which may require further medical examination.
When performing a hearing test at home there is no control of ambient noise in the room. It is also difficult to determine if the speakers or headphones you are using are adjusted properly for the accurate testing of your hearing. When you see an Audiologist, the testing will be done in a uniquely constructed, sound proof booth. You will be tested with equipment and headphones that have been calibrated to ensure accurate testing.
Why do I need an Audiologist?
Hearing aids are medical devices regulated by the FDA and must be recommended and prescribed by licensed hearing professionals. This standard is in place to protect the individual with hearing loss as not all individuals are candidates for hearing aids. An improperly fit hearing aid or hearing aid sold online without a face-to-face evaluation with an audiologist can cause various problems. Without this evaluation, the consumer will not have an otosopic exam (the audiologist will look into the ear canal) and medical problems such as ear drainage or blockages will not be indentified. Additionally, hearing aids that are not adjusted to the individual needs of the patient have the potential for increasing the hearing loss if the devices are not set appropriately. Audiologists can tailor a comprehensive treatment plan for each individual patient that is specific to their unique needs to ensure maximum performance from any device that may be prescribed.