OTCHAA was introduced in Congress on March 21st by the House (H.R. 1652) & Senate (S. 670). This legislation was incorporated into the FDA Reauthorization Act of 2017. The House passed H.R. 2430 on July 12th, and the Senate passed S. 934 on August 3rd. It was signed into law on August 18th.
The general public neither questioned nor noticed. This provision in the FDA Reauthorization Act of 2017 affects everyone.
The OTC Hearing Aid section contains four basic components. The two critical parts are:
Part Two: Requirements of reasonable assurances of safety, adopt output limits of OTC hearing aids, and labeling and consumer protection guidelines.
Part Two states: describe the requirements under which the sale of over-the-counter hearing aids is permitted, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online.
Part Four prohibits State or local government to establish or continue in effect any law, regulation, order, or other requirement specifically applicable to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of over-the-counter hearing aids through in-person transactions, by mail, or online, that is different from, in addition to, or otherwise not identical to, the regulations promulgated under this subsection, including any State or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access over-the-counter hearing aids.
Hearing aids are medical devices prescribed and fitted to patients with hearing loss evaluated by an audiologist—a medical professional with 8-10 years of university study and a doctorate. Some specialize in diagnosing hearing loss and fitting amplifi cation, providing appropriate counseling and aural rehabilitation. This is critical for patient safety, satisfaction, and professional services ensuring success.
Part Two permits and promotes consumer self-diagnosing of hearing loss and fitting hearing aids. Now it is without any supervision, involvement, or intervention by an audiologist or any medical professional. There’s no evaluation or prescription for the consumer. Acquisition will be valid for purchases made in person, by mail, or online.
Part Four: all State and local laws surrounding the sale and fitting of hearing aids are null and void. All safeguards established beforehand or under consideration are eliminated.
These two provisions are a recipe for disaster for people experiencing hearing difficulty. Laws, guidelines, and established common sense regarding medical complaints or anomalies are discarded. Now, a person experiencing hearing difficulty can purchase a device from anywhere and use it to fix their perceived problem.
THE IMPORTANCE OF PROPER DIAGNOSIS
Many afflictions lead a person to believe all they have is hearing loss, so a hearing aid will help. Audiological diagnoses include: impacted earwax, perforated eardrum, cholesteatoma, otitis media, ossicular chain discontinuity, collapsed canal, foreign object in canal, sudden sensorineural hearing loss, acoustic neuroma, site of lesion, etc. Someone without a properly diagnosed medical condition could purchase and wear a hearing aid.
The best upgrade is to change the present law that required a medical evaluation by a physician for amplification. It was in effect decades ago before the inception of audiology, advancement in educational requirements in university study, training, and internship before entering practice. Now, an individual can and will be properly evaluated, diagnosed, treated, and rehabilitated by an audiologist.
Congress overwhelmingly passed this Act. Only two representatives (one each from Texas and Kentucky) and one senator (from Vermont) voted against its passage.
Anyone who suspects a hearing problem should see a board-certified and licensed private practice audiologist (Doctor of Audiology) for a consultation and evaluation. You can reject the provisions negatively impacting public health. An estimated 48-50 million Americans with hearing loss need help. One third of people between 65 and 74 and half of those over 75 experience hearing loss requiring properly fitted amplification. Don’t they deserve the best?