Changes in Audiology Visits at an Academic Audiology Practice Following the Food and Drug Administration Over-the-Counter Hearing Aid Ruling
View abstract on PubMed
Summary
This summary is machine-generated.The FDA
Area Of Science
- Audiology practice and hearing aid technology.
Background
- The U.S. Food and Drug Administration (FDA) permitted over-the-counter (OTC) hearing aid sales nationwide in 2022.
- The impact of this ruling on audiology practices remains under-characterized.
Purpose Of The Study
- To assess changes in the volume of hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) at an academic tertiary care audiology practice after the FDA's OTC hearing aid ruling.
Main Methods
- Billing records for patients aged 18 and older were analyzed.
- HAE and CAE visits were identified using Current Procedural Terminology and Healthcare Common Procedure Coding System codes.
- Visit volumes were compared for 534-day periods before and after the ruling, with sensitivity analysis for seasonality.
Main Results
- Over 534 days post-ruling, hearing aid evaluations (HAEs) increased by 12.0% and comprehensive audiologic exams (CAEs) by 7.3%.
- Combined HAE and CAE visits saw a 7.6% increase.
- Daily visit increases were 0.084 for HAEs and 4.56 for CAEs.
Conclusions
- The FDA's OTC hearing aid ruling did not significantly impact HAE and CAE volumes at this academic audiology practice.
- A slight upward trend in visit volume was observed.
- Further research across diverse practice models is needed to fully understand the ruling's impact on audiology practice volumes.
Related Concept Videos
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
When we hear a sound, our nervous system is detecting sound waves—pressure waves of mechanical energy traveling through a medium. The frequency of the wave is perceived as pitch, while the amplitude is perceived as loudness.
Sound waves are collected by the external ear and amplified as they travel through the ear canal. When sounds reach the junction between the outer and middle ear, they vibrate the tympanic membrane—the eardrum. The resulting mechanical energy causes the...

