Do I Need a Prescription for Hearing Aids?

Currently, hearing aids must be dispensed by a licensed professional, such as an audiologist or a hearing aid dispenser. Many states require that the patient has had a hearing evaluation conducted within 6 months of the hearing aid purchase. Over-the-counter hearing aids have been in the works for years, but there are not any available yet. Right now, only hearing amplifiers can be purchased directly by the consumer. The results of your hearing test, called an audiogram, acts as a prescription for hearing aids. The audiogram contains details about the severity of your hearing loss and will assist in the hearing aid selection and fitting. If you have your hearing tested by one provider, but would like to purchase hearing aids from another, they may allow the existing audiogram to be used as the prescription without retesting your hearing. This will be up to the discretion of the provider.


Why Can’t I Buy Hearing Aids Directly?

Hearing aids are considered either Class 1 or Class 2 medical devices by the FDA, and the FDA restricts their sale to licensed professionals. There are several reasons why the FDA has chosen to restrict the sale of hearing aids.

  1. Hearing aids are not appropriate for everyone with hearing loss.
    • Hearing loss can be caused by medical reasons, such as infection or impacted earwax. A professional will examine your ears and your hearing to determine whether hearing aids are an appropriate treatment option.
  2. Not every type and style of hearing aid is appropriate for every person’s hearing loss.
    • Hearing aids come in many different styles, and the decision is based on more than patient preference. Patients with more severe hearing losses will be limited in their selection by the power of the hearing aids.
  3. Hearing aids must be specially programmed to meet the users’ needs.
    • Incorrectly programmed hearing aids can cause damage to hearing.
    • A professional will be able to fine-tune and program the devices based on the individual’s specific audiogram to ensure optimal results and comfort.

A recent audiogram will act as a prescription for hearing aids. Without one, licensed professionals cannot sell or fit hearing aids for you. In the relatively near future, true OTC hearing aids should be available for purchase. However, the details of these products is currently unknown. Only time will tell the capabilities and cost of OTC hearing aids.

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