Medical Devices

Benefits and Safety Issues


What are the benefits of hearing aids?

  • You will be able to hear sounds that you have not heard previously.
  • You will be able to hear speech over the telephone more clearly.
  • You will be able to communicate more easily with family and friends.
  • Your ability to communicate may improve in noisy listening situations (e.g. a restaurant or in a large group of people).

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Are there limitations with hearing aids?

  • Hearing aids do NOT restore normal hearing. In contrast, eyeglasses can restore 20/20 vision.
  • Hearing aids amplify all sounds, including background noise that you do not wish to hear.
  • Hearing aids require an adjustment period that may take several months. Follow-up visits with the licensed hearing aid dispenser may be needed to take full advantage of the hearing aids.
  • When you begin to use hearing aids, many sounds, including your own voice, might seem too loud.
  • You will need to learn how to adjust the settings for hearing aids with more complicated technology.
  • Hearing aids can be expensive.

To overcome the potential limitations with hearing aids, inclusion of aural rehabilitation during the process of your hearing aid purchase can be helpful. Aural rehabilitation may assist in maximizing the benefits of hearing aids and developing strategies to deal with hearing aid limitations. For more information about aural rehabilitation, please see the American Speech-Language-Hearing Association's (ASHA) "Adult Aural/Audiologic Rehabilitation."disclaimer icon

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Are there safety issues I should know about?

The FDA has issued guidance communicating that we do not intend to enforce the requirement for a medical evaluation or waiver prior to the sale of certain hearing aids for users 18 years of age or older.

While the FDA believes a medical evaluation may not be necessary for people 18 years of age or older before buying hearing aids, if you experience any of the following conditions, you should consult a medical professional:

  • Visible deformities of the ear since birth or from injury
  • Fluid, pus, or blood coming  out of the ear within the previous 3 months
  • Sudden, quickly worsening, or fluctuating hearing loss within the previous 3 months
  • Dizziness
  • Hearing loss in only one ear or a large difference in hearing between ears
  • Ear wax build up or feeling that something is in the ear canal
  • Pain or discomfort in the ear
  • Tinnitus or ringing in one or both of your ears

Please see the American Academy of Otolaryngology-Head and Neck Surgery's website for a complete list of "Red Flags - Warning of Ear Disease."disclaimer icon

Some hearing aids require fitting by a licensed hearing healthcare professional (such as an audiologist or a hearing aid dispenser), so that the amplification matches your hearing loss. If not fitted properly, too much amplification may cause additional hearing loss.

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Page Last Updated: 12/07/2016
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