Benefits, Limitations, Standards (Controls)

BTE hearing aids are Air Conduction 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. restaurant or in a large group of people).


  • 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.

  • infrequent use of a hearing aid does not permit a user to attain full benefit from it.

  • 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.


FDA Standards

All products need to be tested for performance (e.g. electroacoustics) and safety using standardized tests.

All products must follow FDA 'General Controls' to ensure safety and effectiveness:

  • Registration and listing.

  • Good manufacturing practices.

  • Records and reports.

  • No misbranding and/or adulteration.

Hearing Aids with wireless capabilities must also follow 'Special Controls' such as:

  • Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation.

  • Design, description, and performance data should validate wireless technology functions.

Labeling needs to provide:

  • Illustration(s) of the hearing aid, indicating operating controls, user adjustments, and battery compartment.

  • Information on the function of all controls intended for user adjustment.

  • Specific instructions for: Use of the hearing aid, maintenance and care of the hearing aid, replacing batteries, storage, known side effects that may warrant physician, consultation with a physician.