About OTC Hearing Aids

Are Nano’s hearing aids Over the Counter (OTC) Hearing Aids?

  • Yes. Nano’s hearing aids are OTC hearing aids, a category of products defined by the FDA. 

What type of a hearing loss is an OTC hearing aid made for?

  • OTC hearing aids are designed for individuals with perceived mild to moderate hearing impairment.

How does an individual know they have perceived mild to moderate hearing loss?

  • They have trouble hearing speech in noisy places
  • They find it hard to follow speech in groups
  • They have trouble hearing on the phone
  • Listening makes them tired
  • They need to turn up the volume on the TV or radio, and other people complain it’s too loud.

Is there an age requirement to use OTC hearing aids?

  • Yes.  Individuals must be over 18 years of age to use OTC hearing aids. 

What main features make a hearing aid an OTC hearing aid?

  1. The user can change the hearing aid to different programs to hear in different environments. 
  2. The volume can be adjusted.
  3. The output is limited for mild for moderate hearing impairment. 

Are Nano’s hearings aid “Prescription” hearing aids?

  • No.  Because Nano’s hearing aids are OTC, individuals do not need a medical exam, prescription, or a fitting adjustment by an audiologist or hearing professional to use them.    

What are the signs that an individual may need help from a hearing healthcare professional, like an Audiologist?

  • They can’t hear speech even if the room is quiet.
  • They don’t hear loud sounds well, for example, they don’t hear loud music, power tools, engines, or other very noisy things. 
  • If their hearing loss makes it hard to hear loud noises.
  • If a Nano hearing aid does not help them enough.

What are the warning signs that an individual should see a doctor, preferably an ear-nose-throat doctor (an ENT) and NOT buy an OTC hearing aid?

  • Their ear has a birth defect or an unusual shape.  Their ear was injured or deformed in an accident
  • They saw blood, pus, or fluid coming out of their ear in the past 6 months
  • Their ear feels painful or uncomfortable
  • They have a lot of ear wax, or think something could be in their ear
  • They get really dizzy or have a feeling of spinning or swaying (called vertigo)
  • Their hearing changed suddenly in the past 6 months
  • Their hearing changes:  it gets worse then gets better again
  • They have significantly worse hearing in one ear
  • They hear ringing or buzzing in only one ear

Nano Hearing Aids®, Nano CIC®, Nano X2®, Nano Sigma® are registered trademark of Hearing At Home, LLC. Nano Hearing™, For all humankind™, Air Domes™ are trademarks of Hearing At Home, LLC. Nano Hearing Aids® text, logos, taglines, look, feel and trade dress are the exclusive property and trademarks of Hearing At Home, LLC.


Over-the-counter hearing aid. An over-the-counter (OTC) hearing aid is an air-conduction hearing aid that does not require implantation or other surgical intervention, and is intended for use by a person age 18 or older to compensate for perceived mild to moderate hearing impairment. The device, through tools, tests, or software, allows the user to control the hearing aid and customize it to the user’s hearing needs. The device may use wireless technology or may include tests for self-assessment of hearing loss. The device is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online, provided that the device satisfies the requirements in this section.