Changes in Audiology Visits at an Academic Audiology Practice Following the Food and Drug Administration Over-the-Counter Hearing Aid Ruling

Abstract

Purpose:

In 2022, the Food and Drug Administration (FDA) permitted the sale of over-the-counter (OTC) hearing aids nationwide. The impact on audiology practice has not been well characterized. The purpose of this study is to determine if there was a change in the volume of hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) at an academic tertiary care audiology practice following the ruling.

Method:

Data were collected from the billing records of patients ≥ 18 years old. HAE and CAE visits, defined by Current Procedural Terminology and Healthcare Common Procedure Coding System codes, were included. The number of visits was totaled for equal time periods (534 days) before and after October 17, 2022, when OTC hearing aid sales began. Sensitivity analysis (365 days before and after the ruling) accounted for seasonality. Change in visits per day over the entire period was calculated from the slope of the line of best fit.

Results:

The mean (SD) age was 60.5 (18.3) years. There were 20,300 combined HAE and CAE visits. Compared to before the ruling, over the entire study period (534 days), HAE visits increased by 12.0% (n = 57), CAE visits increased by 7.3% (n = 685), and combined visits (HAE and CAE) increased by 7.6% (n = 744) after the ruling. Over the entire study period (534 days), HAE had an increase of 0.084 visits/day, CAE had an increase of 4.56 visits/day, and combined visits (HAE and CAE) had an increase of 4.95 visits/day.

Conclusions:

The FDA OTC hearing aid ruling did not have a meaningful impact on the volume of HAEs and CAEs at an academic audiology practice. We found a small trend toward increased volume. Future studies should investigate visit patterns in other practice models to understand the full impact of the ruling on clinical audiology practice volumes.

As of 2019, over 72 million adults—one in five people—are estimated to have hearing loss in the United States (Haile et al., 2024; Lin et al., 2011). While hearing aids improve communication, social and emotional function, and cognition as well as reduce depressive symptoms (Atef et al., 2023; Mulrow et al., 1990; Tang et al., 2025; Yeo et al., 2023), it is estimated that only 10% of adults in the United States with mild-to-severe hearing loss utilize hearing aids (Haile et al., 2024). Additionally, on average, it takes 9 years from hearing aid candidacy to adoption (Simpson et al., 2019). The low utilization rate is multifactorial and has been attributed to high costs, minimal to no insurance coverage, stigma, discomfort, and low perceived necessity (Desjardins & Sotelo, 2021; Franks & Timmer, 2024; Jilla et al., 2023).

On August 17, 2022, the Food and Drug Administration (FDA) passed a ruling to create a new regulatory category for hearing aids to be sold over the counter (OTC) in pharmacies and other vendors nationwide (FDA, 2022). The ruling aimed to improve hearing aid access, affordability, and uptake for those with mild-to-moderate hearing difficulties (FDA, 2022). The ruling is a reversal of the previous 1977 FDA directive, which prevented the OTC sale of hearing aids and required sales from licensed professionals and only following a medical examination or a signed waiver of evaluation (The New York Times Archives, 1977a, 1977b). It is a continuation of a concerted effort to improve access to hearing aids, building upon the 2016 FDA announcement to stop the enforcement of the required medical examination or signed waiver (FDA, 2016). The sale of OTC hearing aids took effect on October 17, 2022 (FDA, 2022).

The OTC ruling represented a stark change to hearing aid access, which primarily occurred through audiology practices for over 4 decades (Carr & Kihm, 2022; Kochkin, 2009; Picou, 2022). One major question that remains poorly answered is what impact it has had on the volume of visits to audiology practices. In this study, we aimed to investigate the impact of the FDA OTC hearing aid ruling on the volume of hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) at an academic tertiary care audiology practice. We had no specific hypothesis as the OTC ruling could either decrease audiology practice volume through a shift to patients treating themselves or increase audiology practice volume by increased awareness of hearing loss. To our knowledge, this is the first study to investigate the impact of the FDA OTC hearing aid ruling on patient visit volume at an audiology practice.

Materials and Methods

In this retrospective study, data were collected from the billing records of the Columbia University Irving Medical Center (CUIMC) audiology practice associated with the Department of Otolaryngology—Head and Neck Surgery. The CUIMC audiology practice is a comprehensive practice seeing all types of patients (e.g., cochlear implants, hearing aids) Monday through Friday via block scheduling. Given the deidentified nature of the data and its classification as a quality improvement project, a waiver of consent was granted for the study by the CUIMC Institutional Review Board.

Data were included from patients ≥ 18 years old. The initial data set included billing records from the inception of the current electronic health record system at the CUIMC. Given the impact of the COVID-19 pandemic on audiology patient visit volume (Nigam & Neupane, 2023; Ou, 2024; Rahimi et al., 2024), the daily patient visit volume was plotted. The first day used in the study was after the patient visit volume plateaued following return to office in May 2021. This reduces the chance that restrictions from the COVID-19 pandemic biased our results. To our knowledge, there were no other major events (e.g., targeted marketing) that would have impacted HAEs or CAEs during the study period at the CUIMC. The final data set consisted of patient visits between May 1, 2021, and April 2, 2024. This included an equal number of days before (May 1, 2021–October 16, 2022 [534 days]) and after (October 17, 2022–April 2, 2024 [534 days]) the October 17, 2022, date on which the sale of OTC hearing aids began (see Figure 1). We also analyzed 365 days before and after the ruling to account for bias from seasonal differences. All patients ≥ 18 years old presenting to the CUIMC audiology practice during the study period were included.

Figure 1.

Study period in relation to the Food and Drug Administration (FDA) over-the-counter (OTC) hearing aid ruling. The FDA OTC hearing aid ruling went into effect nationwide on October 17, 2022. This study examined visit volumes 534 days before and after the date the ruling was in effect.

We queried patient visit volumes for the two primary types of audiology evaluations at the CUIMC: HAEs and CAEs. HAEs consist of assessments for hearing aids only (Swanson, 2018), while CAEs are visits that include pure-tone air and bone conduction, speech reception thresholds, and word discrimination testing (Tyler et al., 2025). HAEs and CAEs were defined by Healthcare Common Procedure Coding System and Current Procedural Terminology codes V5010 and 92557, respectively (American Medical Association, 2025; Swanson, 2018).

All statistical analyses were performed in July 2024 using R (Version 4.4.0; R Foundation for Statistical Computing) with RStudio (Version 2024.04.1+748; RStudio Inc.). Continuous variables were reported as mean (standard deviation). Analyses were performed for each individual definition of patient visit type (e.g., HAE or CAE) and for the presence of both (e.g., HAE and CAE). The number of visits was totaled for equal time periods in days, before and after the FDA OTC hearing aid ruling, to determine the volume of visits before and after the October 17, 2022, OTC hearing aid sale commencement. Percent change was calculated using the following formula: Percent = $\frac{V_2–V_1}{V_1}$ × 100. To determine the change in visits per day over the entire period as well as before and after the ruling, the slope of the line of best fit based on a daily interval was calculated using the following formula: y = mx + b, where the unit for y was days. The numbers of available audio booths, clinically active providers (which excludes research audiologists), and appointment no-shows were considered to reduce potential bias.

Results

Cohort and Clinic Characteristics

Baseline characteristics appear in Table 1. The cohort included 16,218 patients. The mean (SD) age was 60.5 (18.3) years, with an age range of 18–104 years. The number of available audiology booths (six) and clinically active audiologists (11 before and 11 after the ruling) did not differ across the two periods. In total, there were 20,300 visits for HAEs and CAEs during the study period.

Table 1.

Cohort and clinic characteristics over the entire study period.

Variable	Value
Patients, n	16,218
Age (years), M (SD) [range]	60.5 (18.3) [18–104]
Clinically active audiologists before and after, n	11
Total visits, n	20,300

Number of HAEs and CAEs Before and After the Sale of OTC Hearing Aids

For HAE visits, from May 1, 2021, to October 16, 2022 (534 days), there were 417 visits, and from October 17, 2022, to April 2, 2024 (534 days), there were 474 visits, representing a 12.0% (n = 57) visit increase. For CAE visits, there were 9,361 visits before and 10,046 visits after the ruling, representing a 7.3% (n = 685) visit increase. For combined visits (HAE and CAE), there were combined 9,778 visits before and 10,522 visits after the ruling, representing a 7.6% (n = 744) visit increase. For appointment no-shows, there were 1,700 appointment no-shows before and 1,953 appointment no-shows after the ruling, representing a 14.9% (n = 253) no-show increase (see Table 2).

Table 2.

Hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) before and after the Food and Drug Administration over-the-counter hearing aid ruling.

Visit type	Visit count, n		Percent Δ, % (n)
	534 days before	534 days after
HAE	417	474	13.7 (57)
CAE	9,361	10,046	7.3 (685)
Combined (HAE + CAE)	9,778	10,522	7.6 (744)
No-show	1,700	1,953	14.9 (253)

To control for seasonality, we also considered the number of visits 365 days before and after the ruling. For HAE visits, from October 16, 2021, to October 16, 2022 (365 days), there were 284 visits, and from October 17, 2022, to October 17, 2023 (365 days), there were 310 visits, representing a 9.1% (n = 26) visit increase. For CAE visits, there were 6,452 visits before and 6,705 visits after the ruling, representing a 3.9% (n = 253) visit increase. For combined visits (HAE and CAE), there were combined 6,736 visits before and 7,015 visits after the ruling, representing a 4.1% (n = 279) visit increase. For appointment no-shows, there were 1,180 appointment no-shows before and 1,307 appointment no-shows after the ruling, representing a 10.8% (n = 127) no-show increase (see Table 3).

Table 3.

Change in hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) before and after the Food and Drug Administration over-the-counter hearing aid ruling, accounting for seasonality.

Visit type	Visit count, na		Percent Δ, % (n)
	365 days before	365 days after
HAE	284	310	9.1 (26)
CAE	6,452	6,705	3.9 (253)
Combined (HAE + CAE)	6,736	7,015	4.1 (279)
No-show	1,180	1,307	10.8 (127)

^aPositive numbers indicate an increase in visits.

Change in HAEs and CAEs Before and After the Ruling and Over the Entire Study Period

Compared to before the ruling, the visit-per-day increase was higher after the ruling. Over the entire study period, between May 1, 2021, and April 2, 2024 (1,068 days), HAE had an increase of 0.08 visits/day, CAE had an increase of 4.6 visits/day, and combined visits (HAE and CAE) had an increase of 4.9 visits/day. There was an increase of 14.6 visits/day for appointment no-shows (see Table 4).

Table 4.

Change in hearing aid evaluations (HAEs) and comprehensive audiologic exams (CAEs) over the entire study period.

Visit type	Δ visits/day, na
	534 days before	534 days after	Entire 1,068-day study period
HAE	0.09	0.11	0.08
CAE	2.6	4.3	4.6
Combined (HAE + CAE)	2.6	4.9	4.9
No-show	7.6	9.5	14.6

^aPositive numbers indicate an increase in visits.

Discussion

This study assessed the impact of the October 17, 2022, sale of OTC hearing aids on the volume of patient visits for HAEs and CAEs at an academic tertiary care audiology practice. Comparison of the number of patient visits before and after the ruling indicated a mild trend toward increased volume. The change in visits across the entire study period demonstrated a similar slight increase. This serves to allay concerns that the OTC hearing aid ruling would affect audiology visit volume in academic practice.

There are various factors that could have led to the overall stable or slight increase in patient visits observed. First, the FDA OTC hearing aid ruling may have increased hearing aid–seeking behavior. The day that the sale of OTC hearing aids began, the relative search volume for hearing-related queries on Google increased by over 200%, and in the 2 weeks following the ruling, there was approximately a 25% increase in relative search volume for “hearing aids” (Panth et al., 2023). It is possible that the ruling and media coverage encouraged more patients to seek medical advice and audiologic evaluation. Increased exposure to OTC hearing aids at pharmacies, driving more people to seek a clinical examination, could have had a similar effect. These effects could have offset those who would have seen an audiologist but chose to purchase OTC hearing aids without entering the hearing health care system.

Oppositely, our observations could be due to unrelated external factors, such as trends after the COVID-19 pandemic. While we studied a time period that should have been after the pandemic and its recovery period, we cannot rule out the possibility of lingering effects. For example, given that wearing masks during the COVID-19 pandemic worsened speech understanding (Poon & Jenstad, 2022; Tofanelli et al., 2022), more patients may have sought hearing aids to improve their hearing health afterward. Unfortunately, the current CUIMC electronic record system became active at the beginning of the COVID-19 pandemic. Thus, we are not able to examine prepandemic visit volumes.

While no studies, to our knowledge, have previously investigated the impact of the recent FDA OTC hearing aid ruling on patient visit volumes at audiology practices, there are multiple investigations about the impact of the ruling on hearing aid effectiveness, cost, and utilization, which may inform these findings. First, a randomized control study of 64 participants showed no significant difference in self-reported hearing aid benefit and speech recognition in noise between OTC hearing aids and audiologist-fitted hearing aids (De Sousa et al., 2023). A cross-sectional analysis comparing hearing aid benefit and satisfaction similarly found no difference (Swanepoel et al., 2023). Cost-effectiveness analysis suggests that OTC hearing aids have the potential to be effective at reducing spending and associated with a greater uptake of hearing interventions (Borre et al., 2023). Additionally, this affordability of OTC devices has been recently reported as an enabling factor by OTC hearing aid users (Knoetze et al., 2024). However, there is also preliminary evidence that there is the lowest willingness to pay for OTC hearing aids compared to advanced digital technology hearing aids and rehabilitative services (Jilla et al., 2024). Surveys of low-income community members indicated that the majority are not willing to pay for OTC hearing aids (Johnson et al., 2024), while another survey-based study indicates that those uncertain about insurance coverage are more likely to pursue online hearing health care (Singh & Dhar, 2023). Additionally, following the ruling, hearing health professionals have reported concerns about safety, device handling and self-adjustment, service delivery model, counseling and audiologic care, and optimal benefit and adverse events related to OTC hearing aids (Manchaiah et al., 2023). It is clear that there are many factors that may impact OTC hearing aid–seeking behavior and how patients interact with audiology practices. As more OTC hearing aids enter the market and audiologists increasingly support their implementation, the impact of this new regulatory category will likely evolve.

There are limitations and strengths to this investigation. First, the study is limited in the length of time included before and after the October 17, 2022, sale of OTC hearing aids due to the impact of the preceding COVID-19 pandemic on practice operations and visits. The study would be improved if we could extend the periods before and after to include a larger time window. Particularly, visit volumes should continue to be studied as they could change in the future. For example, the initial burst of interest in hearing health care from the media coverage of OTC hearing aids may wane. In addition, the effect of new developments such as the merging of consumer electronics and hearing aids (such as the Apple AirPods Pro 2 hearing aid feature) is unknown. Study strengths include a stable clinical practice (unchanged number of clinically active audiologists, available audio booths, and clinical sites) and the use of billing records, which should accurately capture visits.

In conclusion, this study provides an early analysis of the possible impact of the FDA OTC hearing aid ruling on academic audiology practice. While we found a small increasing trend, the volume of HAEs and CAEs at this academic audiology practice overall remained meaningfully unchanged following the sale of OTC hearing aids. To fully understand the ruling's impact on clinical audiology practice volumes, future studies should examine visit patterns across various practice models, including additional academic centers and private practice clinics.

Author Contributions

Hannah N. W. Weinstein: Data curation, Formal analysis, Investigation, Validation, Visualization, Writing – original draft, Writing – review & editing. Lauren H. Tucker: Conceptualization, Data curation, Formal analysis, Writing – review & editing. Karla Y. Fernandez: Conceptualization, Methodology, Resources, Validation, Writing – review & editing. Jessica A. Galatioto: Conceptualization, Methodology, Resources, Validation, Writing – review & editing . Justin S. Golub: Conceptualization, Data curation, Funding acquisition, Methodology, Project administration, Resources, Supervision, Validation, Visualization, Writing – review & editing.

Data Availability Statement

Data within this study are available from the corresponding author upon request.

Funding Statement

This work was supported by National Institutes of Health Grant K23AG057832 (awarded to Justin S. Golub), the Triological Society/American College of Surgeons Clinical Scientist Development Award (awarded to Justin S. Golub), and the Columbia University Vagelos College of Physicians and Surgeons Dean's Research Fellowship (awarded to Lauren H. Tucker). Part of this research note was presented as a poster presentation at the 52nd Annual Scientific and Technology Conference of the American Auditory Society held in February 2025 in Scottsdale, Arizona.