Open Access
CC BY-NC-ND 4.0 · Semin Hear
DOI: 10.1055/s-0045-1812034
Review Article

Are Over-the-Counter Hearing Aids Affordable, Accessible, and Satisfactory? Insights from MarkeTrak 25 Survey Data

Authors

  • Erin M. Picou

    1   Department of Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, Tennessee
  • Haiping Huang

    1   Department of Hearing and Speech Sciences, Vanderbilt University Medical Center, Nashville, Tennessee
 

Abstract

The purpose of this study is to review the current state of the over-the-counter (OTC) hearing aid market, specifically focusing on adoption, affordability, accessibility, and satisfaction rates in the MarkeTrak 2025 survey. In a large-scale consumer survey, nearly 5,000 adults with perceived hearing difficulties completed a survey, which asked questions about, among other things, their hearing aids. The results of the survey suggest OTC hearing aids have had a small incremental increase (4 percentage points) in hearing device adoptions, a smaller impact than earbuds with features designed to support hearing loss. The introduction of OTC hearing aids has not affected the adoption rates of prescription hearing aids, where adoption rates (currently 39%) have been stable, or even increased, over the last decade. The data also demonstrate that most OTC hearing aid owners received some professional services, suggesting the accessibility of OTC hearing aids might not be fully successful if success means the ability to acquire hearing aids without professional support. However, OTC hearing aids have been successful in other respects. Relative to prescription hearing aids, OTC hearing aids are more affordable and have similarly high satisfaction rates. The OTC and earbud devices will be interesting to continue to monitor as the market adjusts to the widespread availability of direct-to-consumer solutions for management of hearing difficulties in adults. To date, the availability of OTC hearing aids has not disrupted the prescription hearing aid market, although they are more affordable, and most people who use them are satisfied.


Recently, the Federal Drug Administration (FDA) created a category of hearing aids that could be purchased over-the-counter (OTC), directly by the consumer. This contrasts with historical dispensing practices, where hearing aids were only available from licensed professionals. The journey to the FDA guidance document on OTC hearing aids started in 2009, during a meeting sponsored by the National Institutes of Health. The focus of the meeting was to discuss areas that could improve hearing healthcare for American adults, especially the affordability and accessibility of hearing aids.[1] The focus on affordability and accessibility was driven by the historically low hearing aid adoption rates among adults with hearing loss. At the time, according to the MarkeTrak VIII data, only about 25% of American adults with perceived hearing difficulties owned hearing aids.[2]

To address these low adoption rates, one of the recommendations was to introduce a new category of hearing aids that could be purchased OTC without the requirement of a licensed professional for dispensing devices in this category.[1] Subsequent meetings held by the National Academy of Science, Engineering, and Medicine (NASEM), the FDA, and the Federal Trade Commission reviewed and discussed these and other recommendations. In the end, the NASEM provided its own set of recommendations for the OTC category. The two primary recommendations were: first, remove the requirement for physician clearance, and second, implement a new device category of OTC wearable devices.[3]

These recommendations led to the introduction of the OTC hearing aid act by Senators Grassley and Warren in 2016.[4] The Grassley/Warren bill was included in the 2017 FDA Reauthorization Act, passed by Congress, signed into law by President Trump in 2017. However, the COVID pandemic and other factors delayed the release of the draft rule by the FDA in October 2021. Following extensive public comments, the final rule was released on October 17, 2022. The guidance document required that OTC devices be sold to those with perceived mild-moderate hearing loss, without the requirement to see a hearing professional. The FDA category of prescription hearing aids continues to exist, and it does include the requirement that the device be dispensed by a licensed provider; it also does not include the restrictions of “adult” or “mild-to-moderate” hearing loss.

Only with the most recent survey (MarkeTrak 2025) is it possible to begin to evaluate the impact of the OTC category on American adults who have hearing loss using MarkeTrak data. In the previous survey (MarkeTrak 2022), the OTC final rule was not released, and there were not data available yet regarding the impact of direct-to-consumer devices for adults with hearing loss (although there were some insights related to personal sound amplifiers, which were available for adults without hearing difficulties).[5] Now that the OTC market is several years old, it is possible to examine the impact of the OTC hearing aid category on consumer behavior and preferences. The purpose of this study is to review the evidence from MarkeTrak 25 describing the current state of OTC hearing aids in terms of adoption, affordability, accessibility, and satisfaction rates. Unless otherwise specified, the results below are from respondents who were adults with perceived hearing difficulties (n = 4,993), with a focus on those who owned a hearing device (n = 1,173). [Table 1] displays general demographic information about survey respondents who were hearing aid owners and nonowners. The hearing aid owners answered questions about, among other things, their hearing aids and their satisfaction with them. Full methodological details of the MarkeTrak 25 survey can be found elsewhere in this issue.[6]

Table 1

Demographic information for hearing aid owners and hearing aid nonowners

Demographics

HA owners

Nonowners

All HA owners (n = 1,173); A

Prescription (n = 1,008); B

OTC (n = 136); C

All (n = 1,782); D

Average age

68 D

70 CD

52

57

Median age

72 D

73 CD

58

59

% Male

56%

57%

56%

57%

% Female

44%

43%

44%

42%

% Married/partner

56%

57%

54%

55%

% College degree

47% D

48% CD

37%

35%

% Retired

67% D

70% CD

44%

40%

% Working (FT or PT)

27%

24%

49% B

43% AB

Average income

$91,700 D

$93,300 CD

$79,800

$82,100

Median income

$75,100 D

$77,400 CD

$65,500

$66,600

Note: Letters in a cell indicate this percent is significantly higher than the cell aligned with that column letter. For example, the mean age of all hearing aid owners (68 in column A) was significantly higher than the mean age of all hearing aid nonowners (57; column D).


Hearing Device Adoptions

The MarkeTrak 25 survey demonstrates that 51% of adults with perceived hearing difficulty are using some type of device to address their listening needs, either a prescription hearing aid, OTC hearing aid, an earbud with a feature for “hearing improvement” (such as “conversation boost”), or an implant (e.g., bone-anchored or cochlear implant). As displayed in [Fig. 1], OTC hearing aid adoptions are relatively low. About 6% of adults with hearing difficulty report owning at least one OTC hearing aid; the incremental increase in hearing technology adoptions is only 4% (2% of respondents own both OTC and prescription hearing aids). Also evident in the figure is that the most common type of technology to address listening difficulties is a prescription hearing aid (39%), followed by an earbud with a hearing improvement feature (approximately 21%).

Zoom
Figure 1 Hearing technology adoption rates among those who have self-reported difficulty (n = 4,993). The “any-HA” category includes adoptions for the prescription hearing aids, OTC hearing aids, and unknown hearing aids. Note that many respondents had both prescription hearing aids and earbuds with hearing improvements, so the incremental increase in adoption rates from earbuds was about 8 percentage points. Similarly, 2% of respondents had both prescription hearing aids and OTC hearing aids, so the incremental increase in adoption rates from OTC hearing aids was about 4 percentage points.

As displayed in [Fig. 2], this is a large increase in the adoption of earbuds with hearing improvement features relative to the 2022 survey. Despite the large increase in adoptions of earbuds, the prescription hearing aid adoption rate has been relatively stable (also visible in [Fig. 2]). In fact, adoption rates have increased from 30% in 2015[7] to 39% in 2025. That is, the availability of direct-to-consumer devices (earbuds and OTC hearing aids) has not negatively affected the adoption of prescription hearing aids.

Zoom
Figure 2 Hearing technology adoption rates in the current (MarkeTrak 25) and previous cycle (MarkeTrak 2022) for prescription hearing aids, hearing implants, and earbuds with hearing improvement features. The data represent the percentage of adults with reported hearing difficulties who report having each of these technological solutions.

Hearing Aid Affordability

[Fig. 3] displays the percentage of hearing aid owners who reported that the total cost for one of their hearing aids fell within each price category. Evident in the figure is the disparity between reported prices for prescription and OTC hearing aids. The median cost per prescription hearing aid was reported to be $1,560, which was significantly higher than the reported median cost ($150) per OTC hearing aid. Based on an affordability analysis, Jilla et al[8] reported that an out-of-pocket total cost of $1,500 for hearing aids would be a catastrophic expense for more than half of American adults. Given the MarkeTrak 25 prices per hearing aid, and that most respondents reported owning bilateral prescription hearing aids (83%), the prescription hearing aids represented in MarkeTrak 2025 would not be affordable for most American adults. Conversely, a total, out-of-pocket hearing aid expense of $250 would be affordable to more than 90% of Americans with hearing loss. It appears that the OTC hearing aids reflected in MarkeTrak 25 data would be affordable for most adults with hearing loss. Therefore, the OTC hearing aid category successfully improved the affordability of hearing aids for American adults.

Zoom
Figure 3 Percent of hearing aid owners of prescription hearing aids (left panel) or OTC hearing aids (right panel) who reported paying each price per hearing aid. Owners of prescription hearing aids are in the left panel, and owners of OTC hearing aids are in the right panel.

Hearing Aid Accessibility

The direct-to-consumer aspect of OTC hearing aids should improve accessibility because accessing a provider is no longer a requirement of obtaining a hearing aid. For context, [Table 2] displays the locations where hearing aids were purchased. Interestingly, the MarkeTrak 25 data suggest that the barrier of accessing professional services has not been eliminated with the introduction of the OTC hearing aid category. In the survey, only one in five owners of OTC hearing aids reported receiving no professional services. [Table 3] displays the percent of respondents (owners of prescription and OTC hearing aids) who reported receiving each type of professional service. The table indicates that, although prescription hearing aid owners were significantly more likely to receive professional services, a majority of OTC hearing aid owners also received professional services.

Table 2

Percent of respondents who reported purchasing their hearing aid from each type of location

Where purchased hearing aid(s)

Prescription hearing aid (n = 1,851)

OTC hearing aid (n = 235)

Office, clinic, or center

Audiology private office/clinic

34%[a]

6%

ENT office/clinic with an audiologist on site

23%[a]

9%

Hearing center or store that only sells hearing aids

12%

8%

VA clinic

11%[a]

0%

University or hospital

4%

7%

Retailer or pharmacy: in-store

In-store, from a retailer that sells a range of products (Costco, etc.)

12%

20%[a]

In-store, from a pharmacy that also sells hearing aids (Walgreens, CVS, etc.)

1%

8%[a]

Retailer, pharmacy, or manufacturer: online

Online, from a retailer's website (Costco.com, Walmart.com, BestBuy.com, etc.)

1%

11%[a]

Online, from a pharmacy's website

0%

2%[a]

Online, from a hearing aid brand's website

1%

15%

Online-only retailer

Online, from an online-only retailer (Amazon, eBay, etc.)

0%

11%[a]

Somewhere else

Catalog/mailer

0%

0%

Somewhere else

2%

2%

Given to me/used

<1%

1%

a Percentage significantly different between traditional and over-the-counter hearing aids at a 95% confidence level. Significant differences are also indicated in bold typeface.


Table 3

Percent of respondents who did or did not receive each type of professional service

Prescription hearing aid (n = 1,851)

OTC hearing aid (n = 235)

Did a hearing care professional (HCP) do any kind of evaluation to assess the level/type of loss at the time you got these hearing aids?

Yes (net)

97%[a]

72%

Yes, in-person

94%[a]

64%

• Yes, remotely/virtually

1%

4%[a]

• Yes, both (across multiple visits)

2%

5%[a]

• Yes, but not sure if in-person or virtual

0%

0%

No

0%

23%[a]

Not sure

3%

5%

Was there any kind of assistance from a hearing care professional (HCP) to help them select the hearing aid(s)?

Yes (net)

92%[a]

59%

Yes, in-person

87%[a]

40%

Yes, remotely/virtually

3%

11%[a]

• Yes, both (across multiple visits)

2%

8%[a]

• Yes, but not sure if in-person or virtual

0%

0%

No

3%

35%[a]

Not sure

5%

6%

Did a hearing care professional (HCP) do any kind of initial fitting (to align the hearing aid with the level/type of loss) at the time you got their hearing aid(s)?

Yes (net)

93%[a]

56%

Yes, in-person

89%[a]

42%

Yes, remotely/virtually

2%

9%[a]

Yes, both (across multiple visits)

2%

5%[a]

• Yes, but not sure if in-person or virtual

0%

0%

No

2%

39%[a]

Not sure

6%

5%

a Percentage significantly different between traditional and over-the-counter hearing aids at a 95% confidence level. Significant differences are also indicated in bold typeface.


Although a professional is not required for dispensing, these data indicate a high reliance on professional services, even in the OTC category. Similarly, [Fig. 4] displays the percentage of respondents who report feeling comfortable with each task associated with hearing aid ownership. The figure details that prescription hearing aid owners are less comfortable performing tasks than are OTC hearing aid owners. However, the figure also demonstrates that there is a large percentage of hearing aid owners who do not feel comfortable with important tasks, most of which they would be expected to do without support due to the direct-to-consumer nature of OTC hearing aids (e.g., assessing hearing loss and selecting an appropriate hearing aid).

Zoom
Figure 4 Percent of prescription and OTC hearing aid owners (dark and light blue bars, respectively) who report feeling “fairly” or “somewhat” comfortable performing each task.

Benefit and Satisfaction

Despite the lower cost and reduction in professional support, owners of OTC and prescription hearing aids are similarly satisfied with their devices. Specifically, as described by Picou,[9] 83 and 76% of prescription and OTC hearing aid owners, respectively, reported they were satisfied with their devices. However, OTC hearing aid owners were less likely than their peers with prescription hearing aids to be “promoters” of their hearing aids. Given the similar satisfaction rates, it is unclear why OTC hearing aid owners are less likely to be “promoters.” Based on existing evidence demonstrating the importance of family-centered services for improving being a “promoter,”[10] it is possible that OTC hearing aid owners might be less likely to be “promoters” because of their satisfaction with the professional services they received throughout their hearing aid journey.

Consistent with this hypothesis, even with OTC hearing aids, it's worth noting that the hearing aid satisfaction rates were lower for those who did not receive professional services than for those who did receive the services.[9] Therefore, those who acquired hearing aids without a professional were less likely to be successful users (at least less satisfied), regardless of whether they were OTC or prescription hearing aid owners. Importantly, without professional services, some hearing aid owners are inappropriately fit in the OTC category. For example, 71% of OTC hearing aid owners report having bilateral hearing aids, but only 66% of OTC hearing aid owners report having bilateral hearing loss. It is possible that, for 5% of the respondents, purchasing a pair of OTC hearing aids was the best or easiest option, even if they had unilateral hearing loss. It is also possible that, with professional services, they could have purchased a single hearing aid instead of two hearing aids. This type of result highlights the importance of professionals in selecting the right hearing aid(s) based on a person's hearing difficulties, and also highlights an opportunity for better guidance to align purchases with consumer needs in the OTC hearing aid category


Conclusion

The MarkeTrak 25 data suggest that OTC hearing aids have had a small, incremental improvement (4 percentage points) in hearing device adoptions. This impact was smaller than the one made by earbuds with “hearing improvement” features, which improved adoption rates incrementally by 8 percentage points. The adoption rate of prescription hearing aids (currently 39%) has been stable over the last decade and has been largely unaffected by the availability of OTC hearing aids or earbuds. This early evidence suggests that OTC hearing aids have not been a large disruption in the prescription hearing aid market. It also supports the notion that affordability is not the only limiting factor in low hearing aid adoption rates.[11] Hearing aid adoption decisions are multifaceted, depending on individualized personal factors, such as perceived hearing difficulty,[12] degree of hearing loss,[13] stigma,[14] and social support.[15]

The MarkeTrak 25 data also demonstrate that OTC hearing aids are not necessarily widely accessible, if accessibility means not being reliant upon professional services. Most OTC hearing aid owners received, or would have liked to have received, service support from hearing care professionals. In addition, some OTC hearing aid owners are inappropriately fit, based on their self-described hearing abilities. However, OTC hearing aids have been successful in other respects. Relative to prescription hearing aids, OTC hearing aids are more affordable and, despite being less expensive, have similarly high satisfaction rates. The direct-to-consumer devices, such as OTC hearing aids and earbuds with hearing improvement features, will be interesting to continue to monitor as the market adjusts to the widespread availability of such OTC solutions for adults with perceived hearing difficulties. To date, they have relatively limited impact on the prescription hearing aid market.



Conflict of Interest

None declared.


Address for correspondence

Erin M. Picou, Au.D., Ph.D.
1215 21st Ave. South, Room 8310, Nashville
TN 37232   

Publikationsverlauf

Artikel online veröffentlicht:
03. Oktober 2025

© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

Thieme Medical Publishers, Inc.
333 Seventh Avenue, 18th Floor, New York, NY 10001, USA


Zoom
Figure 1 Hearing technology adoption rates among those who have self-reported difficulty (n = 4,993). The “any-HA” category includes adoptions for the prescription hearing aids, OTC hearing aids, and unknown hearing aids. Note that many respondents had both prescription hearing aids and earbuds with hearing improvements, so the incremental increase in adoption rates from earbuds was about 8 percentage points. Similarly, 2% of respondents had both prescription hearing aids and OTC hearing aids, so the incremental increase in adoption rates from OTC hearing aids was about 4 percentage points.
Zoom
Figure 2 Hearing technology adoption rates in the current (MarkeTrak 25) and previous cycle (MarkeTrak 2022) for prescription hearing aids, hearing implants, and earbuds with hearing improvement features. The data represent the percentage of adults with reported hearing difficulties who report having each of these technological solutions.
Zoom
Figure 3 Percent of hearing aid owners of prescription hearing aids (left panel) or OTC hearing aids (right panel) who reported paying each price per hearing aid. Owners of prescription hearing aids are in the left panel, and owners of OTC hearing aids are in the right panel.
Zoom
Figure 4 Percent of prescription and OTC hearing aid owners (dark and light blue bars, respectively) who report feeling “fairly” or “somewhat” comfortable performing each task.