The FDA Has Strict Regulations Regarding The Labeling And Sales Of Hearing Aids

The FDA has strict regulations regarding the labeling and sales of hearing aids. Those devices that do not specifically follow the FDA regulations are not allowed to advertise themselves as hearing aids, only listening or sound amplification devices. Most of the FDA regulations cover the labeling of the actual device and the requirements for information that must be included in the user’s manual for a hearing aid.

FDA regulations consider a hearing aid as any device that is specifically designed for, or represented as, a device that assists a person with a hearing impairment. The companies who sell hearing aids are called “dispensers”. The dispenser of hearing aids is advised to recommend the patient purchasing a hearing aid should first consult a hearing professional prior to the purchase.

The hearing aid label is required to be permanently marked with specific information that the user should be able to see clearly. There should be a plus sign marked to indicate the direction replacement batteries should be inserted. The remaining labeling for the hearing aid is required to be included in the instructional manual. This information should include a clear picture of the hearing aid, which indicates adjustments and operating controls that may need to be manipulated by the user.

All additional information that is required to be included in the instruction manual is provided so the user can easily operate their hearing aids. Specific instructions should be included to allow the patient to maintain and clean the hearing aids and change the batteries. There should also be patient warnings for possible side effects, including skin irritation and accumulation of ear wax.

The FDA regulations are intended to protect patients from manufacturers of listening devices that are not actually hearing aids. Many of the products offered on television to amplify someone’s hearing are not actually hearing aids. Those manufacturers are required to include a disclaimer that advises they are not regulated hearing aids. Anyone suspecting they are experiencing hearing loss should consult an audiologist for a full exam and prescription for hearing aids, if necessary.

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