Board Guidance
As a result of the FDA final rules on over-the-counter hearing aids (see FDA Regulations for Over-the-Counter Hearing Aid Sales) the Board has been requested to provide guidance to licensees. The final FDA rule creates two classes of hearing aids, over-the-counter (OTC) and prescription, where one previously existed. The sale of OTC hearing aids is not within the purview of the board, the ruling qualifies that OTC hearing aids are only intended for adults with perceived mild-to-moderate hearing loss. As such, it would be unsafe for licensees to recommend over-the-counter hearing aids for children. Licensees are to continue to follow all state statutes under Article 22. Licensure Act for Speech and Language Pathologists and Audiologists and rules under the North Carolina Administrative Chapter 64, surrounding assessment and dispensing of traditional or “prescription” hearing aids for adults and children.
Online Sale of Hearing Aid Policy
As a result of the Food and Drug Administration (FDA) OTC Hearing Aid Regulations, the Board is providing additional guidance to licensees regarding the state’s statutory requirements. The strict sale of Over-The-Counter (OTC) hearing aids without fitting and maintenance by an Audiologist shall not fall under the purview of the Board.
The online sale and fitting of a traditional or “prescription” hearing aid falls under the jurisdiction of NC Administrative Code Title 21, Chapter 64 sections .0215 Standard of Practice for Audiological Evaluations and .0220 Standards for Audiologists who Dispense Hearing Aids. Licensees are required to follow all rules related to dispensing prescription hearing aids no matter the service delivery model.
Fitting and Maintaining OTC Hearing Aids Policy
If an Audiologist fits, programs, orients and/or maintains an OTC hearing aid for a patient; it falls under the practice of Audiology and the jurisdiction of the NC Board of Examiners for Speech and Language Pathologists and Audiologists.
Fitting and Maintaining “Prescription” Hearing Aids Policy
For “prescription” hearing aids, licensees are to continue to follow all state statutes under Article 22 Licensure Act for Speech and Language Pathologists and Audiologists and rules under the North Carolina Administrative Code Title 21, Chapter 64, surrounding the assessment and dispensing of traditional or “prescription” hearing aids for adults and children.
Reminder for Licensees
OTC hearing aids are only intended for adults. Therefore, it would be unsafe for licensees to recommend OTC hearing aids for children (less than the age of 18).
Additional External Resource Links
- Guidance for Industry and FDA Staff: This guide supersedes the February 25, 2009 version.
- Federal Register: FDA Public Inspection
- American Academy of Audiology: OTC Hearing Aid Resource Page
- ASHA: OTC Hearing Aid Toolkit
- US FDA: OTC Hearing Aids: What You Should Know