Abstract
Introduction:
Over-the-counter (OTC) hearing aids have become increasingly accessible, yet limited information exists regarding their online listings and marketing practices. This study evaluated cost, satisfaction ratings, review, volume, readability of product descriptions, and Food and Drug Administration (FDA) clearance status of OTC hearing aid listings on Amazon.com.
Materials and Methods:
This cross-sectional, descriptive study analyzed 138 Amazon OTC hearing aid listings. Listing characteristics were extracted, and FDA clearance was verified. Analyses included descriptive data on listing characteristics and nonparametric analysis of key variables: price, FDA-clearance status, device type, and form factor. Readability indices were used to assess the accessibility of product descriptions.
Results:
Of the 138 listings analyzed, 92 listings (66.7%) identified their product as “OTC hearing aids”, while only 37 (26.8%) were verified as FDA-cleared. FDA-cleared devices cost significantly more than non-FDA cleared devices. Behind-the-ear (BTE) devices had a significantly higher number of reviews compared to in-the-ear (ITE) devices. The readability of product descriptions was advanced, ranging from 11th-grade to college graduate levels. Additionally, 52 listings (37.7%) lacked specific marketing for mild-to-moderate hearing loss, and 13 (9.4%) were marketed to those with hearing loss beyond mild-to-moderate.
Discussion:
Amazon listings for OTC hearing aids reveal significant inconsistencies in marketing and labeling, including misleading FDA clearance claims and inadequate accessibility of product information. Advanced readability levels and marketing for hearing loss degrees beyond mild-to-moderate further impede consumers’ ability to make informed purchasing decisions. These findings highlight the urgent need for stricter regulatory oversight and improved dissemination of accurate, accessible consumer information.
INTRODUCTION
Hearing loss is one of the most common chronic health conditions, estimated to impact 1 in 5 people around the world, projected to rise to 1 in 4 people by 2050 (1). Despite the efficacy of hearing aids in mild to moderate hearing loss, only one in four candidates in the US obtain a hearing aid (2). Poor utilization is likely due to a combination of factors including device cost, poor access to healthcare professionals, low perceived need and stigma associated with wearing a device (3). In order to combat some of these factors, U.S. Congress passed the Over-the-Counter (OTC) Hearing Aid Act in 2017, which required the U.S. Food and Drug Administration (FDA) to establish regulations for hearing devices that consumers could purchase without consultation from a healthcare provider (4). These devices were known as OTC hearing aids, and their sale began in the US in October 2022 (5).
In the two years following the implementation of the OTC Hearing Aid Act, the availability of these devices in the market has expanded exponentially. Online retailers including Amazon.com have become an easy one-stop source for individuals to compare a wide variety of hearing aid options, followed by rapid product delivery. When purchasing online, consumers have rapid access to countless choices, including hearing enhancers such as Personal Sound Amplification Products (PSAPs) which are intended for people with normal hearing (6). Additional options include modified headphones with smartphone connection capabilities, prescription-grade self-fitting hearing aids, and big-name commercial OTC options (6). The extensive availability of options does not necessarily ensure a suitable device for consumers. Research indicates that even before the introduction of OTC hearing aids, individuals with hearing loss frequently used hearing devices such as PSAPs designed for individuals with normal hearing (7,8). The creation of the category of OTC hearing aids was intended specifically for individuals with perceived mild-to-moderate hearing loss, although the ability of these consumers to evaluate their personal degree of hearing loss without healthcare input is likely varied. Despite these potential drawbacks, the prevailing opinion is that improving access to such devices outweighs these concerns (9).
With the establishment of the OTC hearing aid category, the FDA implemented various regulatory measures to ensure product safety and efficacy. Among these, OTC self-fitting hearing aids must receive 510(k) FDA clearance, signifying a comprehensive review process, referred to throughout this study as “FDA-cleared” (10). In contrast, OTC pre-set hearing aids require only FDA registration, with no equivalent clearance requirement. Notably, current regulations do not mandate advertisers to disclose FDA clearance status, nor do they specify the information that retailers must include in online listings (4). Additionally, the FDA defined OTC hearing aids as devices designed for adults with perceived mild to moderate hearing loss, available without the involvement of a licensed professional, explicitly excluding hearing amplifiers, which are not tailored for hearing loss and were already on the market (5). To ensure the accessibility of OTC hearing aids, it is critical that these devices are easy to locate and that potential users can navigate the overwhelming volume of available information to select appropriate products (10). Therefore, this study aimed to 1) provide an overview of OTC hearing aids available on Amazon.com; 2) identify trends related to cost, consumer satisfaction ratings, readability of product descriptions, and other metrics such as device type, form factor and smartphone app; 3) confirm FDA clearance status; and 4) evaluate listing accessibility via readability indices.
MATERIALS and METHODS
This study employed a cross-sectional, descriptive study design to characterize OTC hearing aids available on Amazon and identify trends among key characteristics through quantitative analysis.
Data Extraction
An online search using the search phrase “OTC hearing aids” was conducted on Amazon.com using a guest browser to minimize the influence of personalized search results. Product listings were recorded in an Excel spreadsheet in the order they appeared on the search results page. Figure 1 presents the details of search and data extraction process and timescales. Recordings or listing URL, listing title, and company occurred in a single session on April 3, 2024. Both sponsored and standard listings were documented to reflect the typical consumer experience. This study used a consecutive (non-randomized) sampling approach, as approximately 71% of consumers browse only the first 1–3 pages of search results, data collection was limited to the first three pages, yielding 144 listings (11). Duplicate listings were included only once, and six listings were no longer available on Amazon before primary data could be extracted and were therefore excluded, resulting in 138 initial listings for analysis. Data collection was obtained by a single researcher for consistency, and a second researcher cross-checked the FDA clearance variable for accuracy and reliability. The primary data extraction from these listings occurred between April 3, 2024 and June 23, 2024 in order of appearance.
Figure 1:
Listing Attrition Over Time
Due to fluctuations in Amazon listings over time as well as additional items added to analyze throughout the research period, some listings were taken down before all data could be analyzed. This figure demonstrates the attrition of these listings at each stage of the research process.
Key data extracted included price, device type (i.e., self-fit vs pre-set), form factor (i.e., in-the-ear [ITE] or behind-the-ear [BTE]) and FDA clearance status. FDA clearance was verified by cross-referencing the FDA database (12). Additional data included the number of reviews, advertisements for FDA clearance, smartphone app availability, advertised hearing loss range (e.g., mild-moderate vs moderate-severe), seller account name, country of origin, and clarity of the return policy. Despite the potential for fake reviews, Amazon’s use of AI technology to block over 200 million fake reviews in 2022 supports their inclusion as a relevant metric (17).
Secondary data extraction was conducted to assess the readability of the product descriptions using Readability Studio software between June 24, 2024, until September 2, 2024, utilizing the same links to access the previous listings (16). The Flesch-Kincaid (F-K), FORCAST and Simple Measure of Gobbledygook (SMOG) tests were used to evaluate language accessibility (13–15).
Final data points related to return policy and hearing loss marketing language were extracted during single sessions on October 6 and 7, 2024. Listings that had been removed by these dates were excluded from those respective analyses.
Due to the dynamic nature of Amazon listings, product availability fluctuated during the study. Listings that became unavailable after the initial data collection were retained in the primary dataset to preserve the integrity of the market snapshot as of June 2024. However, listings that were unavailable at the time of secondary or final data collection were excluded from those specific analyses (34 unavailable for readability analysis, 51 for return policy, and 52 for marketing language) as outlined in Figure 1.
Data Analysis
Descriptive statistics including the mean, median and range were calculated for the device characteristics. Both means and medians were reported for key variables to offer a comprehensive summary of central tendency. A total of 138 listings with their respective data were then analyzed. Four key variables were isolated for analysis: price, FDA-clearance status, device type, and form factor. The data were analyzed using Statistical Package for the Social Sciences (SPSS), version 28.0.1.0 (18). Normality was first assessed using standard tests for normality (e.g., Shapiro-Wilk), which indicated that the data did not meet the assumptions of normality for parametric tests. As a result, nonparametric analyses were conducted to explore the relationships between variables, utilizing the Kruskal-Wallis H test and the Mann-Whitney U test. A p-value of < 0.05 was considered statistically significant. Additional characteristics which were recorded, but not statistically analyzed, included the presence of accompanying smartphone app, whether they advertised as OTC hearing aids, marketed specific hearing loss ranges, whether they were marketed to adults, and the presence of a clear return policy.
RESULTS
Device Characteristics
Table 1 summarizes the key characteristics of OTC hearing aids listed on Amazon. Prices varied widely, with listings costing as little as $19.70 and as much as $2,950 with a mean price of $322. The mean consumer rating was 3.9/5 stars. Most devices (n = 108, 78.3%) had pre-set hearing modes, while 30 (21.7%) were self-fitting. Of all the listings (n = 138), 49 (35.5%) advertised an accompanying smartphone app. Regarding form factor, 77 (55.8%) listings were ITE models, and 61 (44.2%) were BTE. Five listings (3.6%) did not market towards a specific degree of hearing loss, while 13 (9.4%) advertised support for severe, significant or advanced hearing loss. The mean readability scores of the product descriptions from the secondary data extraction (total of 110 listings) indicated a college-level reading difficulty: Flesch-Kincaid grade level of 13.0, FORCAST grade of 11.9, SMOG grade of 14.3, and Flesch Reading Ease mean of 40.7. Most of the listings (119, 86.2%) marketed to adults, while 13 (9.4%) did not. Additionally, many listings clearly discussed some form of return policy (82 listings, 59.4%), while five listings (3.6%) did not.
Table 1:
Summary of Characteristics of Over-the-Counter Hearing Aids Listed on Amazon
| Characteristic | All listings (n = 138) |
FDA Cleared (n = 37) |
Not FDA Cleared (n = 101) |
|---|---|---|---|
|
| |||
| Price in $, mean (SD) | 322.0 (407.4) | 697.7.1 (616.5) | 184.4 (176.1) |
| Median; range | 199; 19.7 – 2950.0 | 499.0; 149.0 – 2950.0 | 140.0; 19.7 – 1000.0 |
| Amazon rating, mean (SD) | 3.9 (0.8) | 3.8 (0.8) | 4.0 (0.7) |
| Median; range | 3.9; 1.0 – 5.0 | 3.7; 1.6 – 5.0 | 4.0; 2.5 – 5.0 |
| No of reviews, mean (SD) | 160.1 (541.0) | 89.9 (130.4) | 257.2 (748.6) |
| Median; range | 22.5; 1.0 – 4570.0 | 36.0; 1.0 – 633.0 | 22.0; 1.0 – 4570.0 |
| Flesch Kincaid, mean (SD) | 13.0 (2.4) | 13.0 (2.6) | 13.0 (2.3) |
| Median; range | 12.7; 8.3 – 19.0 | 12.7; 8.3 – 19.0 | 12.7; 9.1 – 19.0 |
| Flesch Reading Ease, mean (SD) | 40.7 (16.5) | 42.2 (24.4) | 40.0 (11.2) |
| Median; range | 41.0; 0.0 – 158.0 | 40.0; 0.0 – 158.0 | 43.0; 8.0 – 60.0 |
| FORCAST, mean (SD) | 11.9 (1.5) | 12.0 (1.2) | 11.8 (1.6) |
| Median; range | 11.7; 10.2 – 22.5 | 12.0; 10.2 – 16.7 | 11.6; 10.2 – 22.5 |
| SMOG, mean (SD) | 14.3 (2.2) | 14.3 (3.0) | 14.3 (1.7) |
| Median; range | 13.9; 10.3 – 26.9 | 14.1; 10.3 – 26.9 | 13.9; 10.6 – 19.0 |
| FDA Cleared | |||
| Yes | 31.0 (22.5%) | 31.0 (83.8%) | - |
| Yes only if made by specific manufacturer | 6.0 (4.4%) | 6.0 (16.2%) | - |
| No | 97.0 (70.3%) | - | 97.0 (96.0%) |
| No but claim to be | 4.0 (2.9%) | - | 4.0 (4.0%) |
| Device type | |||
| Pre-set | 108.0 (78.3%) | 19.0 (51.4%) | 89.0 (88.1%) |
| Self-fit | 30.0 (21.7%) | 18.0 (48.7%) | 12.0 (11.9%) |
| Form factor | |||
| ITE | 77.0 (55.8%) | 18.0 (48.7%) | 59.0 (58.4%) |
| BTE | 61.0 (44.2%) | 19.0 (51.4%) | 42.0 (41.6%) |
| Accompanying smartphone app | |||
| Yes | 49.0 (35.5%) | 25.0 (67.6%) | 24.0 (23.8%) |
| No | 89.0 (64.5%) | 12.0 (32.4%) | 77.0 (76.2%) |
| Advertised as “OTC HA” | |||
| Yes | 92.0 (66.7%) | 35.0 (94.6%) | 57.0 (56.4%) |
| No | 46.0 (33.3%) | 2.0 (5.4%) | 44.0 (43.6%) |
| Marketed audience i.t.o HL | |||
| Mild-to-moderate HL | 68.0 (49.3%) | 20.0 (54.1%) | 48.0 (47.5%) |
| Severe / significant / advanced HL | 13.0 (9.4%) | 1.0 (2.7%) | 12.0 (11.9%) |
| HL (no degree specified) | 5.0 (3.6%) | 2.0 (5.4%) | 3.0 (3.0%) |
| Listings removed* | 52.0 (37.7%) | 14.0 (37.8%) | 38.0 (37.6%) |
| Marketed to adults (18 years+) | |||
| Yes | 119.0 (86.2%) | 23.0 (62.2%) | 96.0 (95.0%) |
| No | 13.0 (9.4%) | 10.0 (27%) | 3.0 (3.0%) |
| Listings removed* | 6.0 (4.4%) | 4.0 (10.8%) | 2.0 (2.0%) |
| Return policy | |||
| Yes | 82.0 (59.4%) | 29.0 (78.4%) | 53.0 (52.5%) |
| No | 5.0 (3.6%) | 2.0 (5.4%) | 3.0 (3.0%) |
| Listings removed* | 51.0 (37.0%) | 6.0 (16.2%) | 45.0 (44.6%) |
Note: FDA = Food and Drug Administration, SD = Standard Deviation, ITE = In-the-ear, BTE = Behind-the-ear, OTC = Over-the-counter, i.t.o = in terms of, HL = Hearing loss. Percentages may not total exactly 100% due to rounding.
Listings removed refers to listings which were removed prior to obtaining this specific piece of data. These were listed separately, as there is no way to verify once a listing is removed.
Of the 138 total listings analyzed, 92 (66.7%) identified their product as an “OTC hearing aid,” yet only 37 (26.8%) were verified as FDA-cleared. FDA-cleared hearing aids had a mean cost of $697.91 and an average rating of 3.8 stars, while non-cleared devices had a lower mean cost of $184.40 but a slightly higher mean rating of 4.0 stars. FDA-cleared devices had a mean number of reviews of 89.9 per listing, while non-cleared devices had a mean number of reviews of 257.2 per listing. Four devices claimed FDA clearance that could not be verified, and they were included in the non-cleared category.
Fluctuations in Amazon listings during data collection were noted. While only 6 listings (4.2%) were taken down before data on price, ratings, marketing to adults, and FDA clearance could be collected and were therefore excluded from any analysis, 34 listings (24.6%) were removed before readability data were analysed. Fifty-one listings (37.0%) were removed before return policy data were analysed, and 52 listings (37.7%) were removed before return policy and marketing in respect to hearing loss were analysed.
With regards to marketing towards degrees of hearing loss, 68 of the 86 listings available for analysis (79.1%) explicitly specified they are intended for those with mild-to-moderate hearing loss, while 13 (15.1%) of the listings utilized language consistent with more profound hearing loss (“severe”, “significant”, “advanced”).
Associations Between OTC Characteristics
Key variables analyzed included price, FDA-clearance status, device type, and form factor (Supplemental Table 1). FDA-cleared devices had a mean cost of $697.71 while not FDA-cleared devices had a mean cost of $176.10 (p = 0.004). Self-fit devices on average costed $920.90, while pre-set devices had average price of $196.72 (p < 0.001). Form factor also influenced price, with BTE devices being significantly costlier than ITE devices with mean costs of $391 and $319, respectively (p < 0.001). Additionally, BTE devices had significantly more reviews than ITE devices, at 289.9 and 139.1 respectively (p = 0.02), though consumer ratings did not differ significantly (BTE 3.90, ITE 3.91; p = 0.253). Other associations among variables were not statistically significant (Supplemental Table 1).
DISCUSSION
This study examined key characteristics of OTC hearing aids listed on Amazon.com, focusing on FDA-clearance status, price, device type, form factor, readability, and consumer reviews. OTC hearing aids are a newer category of hearing devices on the market created by the FDA to increase accessibility and use of hearing aids by consumers, which are meant to adhere to specific standards to ensure quality and improvement of patient safety. OTC hearing aids may be contrasted with the designation direct-to-consumer hearing aids, which indicates simply that consumers are able to purchase hearing products without the need for a healthcare professional or a prescription. Results revealed notable gaps in regulation and marketing, with irregularities in target population specifications and the lack of clear return policy information across many listings. These issues highlight the need for improved transparency and stricter regulation in the OTC hearing aid market.
Not all the OTC hearing aids available on Amazon were FDA cleared, and self-fitting devices were found to be significantly more expensive than pre-set models. The higher cost of self-fitting devices is likely attributable to the development and maintenance of personalization software, smartphone app compatibility, and Bluetooth capabilities. While this technology enhances functionality, it also increases the financial burden on consumers.
In comparison to traditional prescription hearing aids, OTC hearing aids offer a cost-effective alternative. Prescription hearing aids, on average, cost between $900–$2,500 per device in 2015/2016, with bilateral costs ranging from $3,500–$5,000 (19,20). Prior reports confirm that health insurance typically does not cover hearing aid costs, suggesting that these costs are out-of-pocket for most patients (19). While still expensive, our study found that FDA cleared hearing devices averaged $697.71 per pair of devices on Amazon.com which is more cost-effective for consumers. This lower cost, in conjunction with the elimination of clinic appointments, results in significant cost savings and improved accessibility for most patients.
Per the recommendations of American Speech-Language-Hearing Association (ASHA) and the American Academy of Audiology (AAA), the use of OTC hearing aids should be used only for adults experiencing mild-to-moderate hearing loss, as those with more significant hearing deficits should be seen by an audiologist to get adequate evaluation, device fitting, and monitoring (21). In contrast, the FDA has suggested that consumer perception of mild-moderate hearing loss is sufficient to qualify for OTC hearing aids, eliminating the need for a formal diagnosis. Across all listings analyzed, 79.1% specified mild-to-moderate hearing loss as the target population, while 15.1% marketed their products as capable of treating patients with “severe,” “significant,” or “advanced” hearing loss. If the aim of OTC hearing aids is to enhance accessibility and provide care to those in need, it is crucial to ensure that individuals requiring a higher level of care are directed to seek medical attention. This highlights the importance of regulating the language used by sellers in online product listings to prevent misinformation and guide consumers appropriately.
While OTC hearing aids are more affordable than traditional prescription hearing aids, consumers may be influenced to purchase devices that are not clinically recommended, potentially impacting customer satisfaction and hearing improvement. Previous research on Amazon.com customer comments for direct-to-consumer hearing devices identified concerns such as fit, comfort, sound quality, cost, and ease of use as common contributors to negative reviews (8). Another key consideration is the accessibility of information in product listings. Due to the language complexity and advanced reading levels associated with device listings, they may not effectively communicate with the general public (22). Based on an evaluation of health literacy in the U.S. population (National Assessment of Health Literacy), it is recommended that informational health materials are written at an elementary reading level (23). Despite this, most Amazon listings were found to be at a college reading level, making this information potentially inaccessible to many consumers.
Although the OTC Hearing Aid Act improved access to devices, it did not establish guidelines for online listings to ensure that hearing health information is accessible to the broader population, which is essential for informed decision-making (10). Furthermore, there is limited enforcement of regulations regarding advertisement, marketing, and listing guidelines for hearing aid devices offered on websites like Amazon.com. Developing and implementing strategies to help consumers select appropriate OTC devices for their specific hearing loss and lifestyle would be a valuable step forward. These strategies could include a required sub-listing on the product page where a company must specify whether the device is 510(k) FDA cleared prior to posting their listing, as well as a required location to list the target degree of hearing loss, with the only choices being perceived mild-to-moderate hearing loss or no hearing loss.
Emerging evidence supports the efficacy and effectiveness of OTC hearing aids for individuals with mild-to-moderate hearing loss (24,25). However, as OTC hearing aids gain popularity, addressing marketing concerns and improving information accessibility is critical. While these devices provide affordable and accessible options for individuals with mild-to-moderate hearing loss, their increasing presence underscores the urgent need for clearer regulations. As consumer products continue to be promoted as hearing aids, ensuring that individuals have access to accurate, comprehensive information is essential for enabling informed decision-making regarding their suitability for specific hearing needs.
Given some of these listings’ lack of clarity regarding target population, marketing towards unsuitable degrees of hearing loss, not readily verifiable claims of FDA clearance, and very high reading levels of listings, the current OTC hearing aid marketplace seems to be falling short of its goal to provide accessible and effective assistance to consumers. These findings underscore the importance of market regulation of OTC hearing aids online as well as in stores, and additionally an opportunity to provide unified patient guidance to help them purchase the product that is best for them.
There is very little research available regarding regulatory standards of online medical device sales. In a similar study, a group in the UK evaluated the presence of safety information in online listings for over-the-counter bruxism splints (26). They found very little safety information on listing websites. There was legislation in place for providing safety information within the box itself, but no such regulation required of the online listings. The absence of further comparable work in the healthcare device space suggests a future direction of research to ensure consumers can make safe, informed purchasing decisions online.
Study Limitations
This study presented with some limitations. First, it represents a small-scale analysis, including only 138 listings from a single search conducted on a specific date, providing a limited snapshot of the available OTC hearing aid options on Amazon.com. The search was restricted to a single platform (Amazon.com) and used one search phrase, which may not align with the diverse search behaviors of typical consumers. Moreover, the study used a consecutive (non-randomized) sampling method, limited to the first three pages of Amazon search results. This may not capture the full range of available OTC hearing aids and could limit generalizability. Additionally, the use of a guest browser minimized personalization, but most consumers browse with an account, where personalized optimizations may alter the results. Thus, the listings analyzed may not fully reflect the average user’s experience.
Another limitation is the high turnover rate of Amazon listings, with several products analyzed either becoming unavailable or being removed during the study. As a result, the findings may not completely capture the dynamic nature of the market. While the authors were unable to find clear consensus on why this may occur, some potential causes for the high product turnover could include poor ratings resulting in sellers taking down the listing and possibly re-listing to re-set their ratings, removal due to regulatory compliance concerns, and lack of brand reliability. It is also possible that the life cycle of an Amazon listing is much shorter than the authors predicted, regardless of item type, however at the time of publication the authors were not aware of any data supporting this.
Furthermore, determining FDA-clearance status was challenging due to incomplete listing information, such as missing manufacturer names, model numbers, or product identifiers. The complexity of navigating the FDA database added to these difficulties. There is also a potential gap in consumer knowledge, as they may not be aware of the FDA-clearance requirements. Knowledgeable consumers seeking to verify FDA-clearance may encounter similar barriers, further complicating their decision-making process.
Future Directions:
Subsequent research could consider expanding the scope of analysis beyond Amazon.com virtually or explore similarities/differences between advertising practices of virtual hearing aids versus in-store hearing aids. Another potential new direction for future studies is analysis of regular vs rechargeable batteries within OTC hearing aids. This is a factor that is frequently highlighted in commercial advertising and could be relevant to consumer decision-making. Finally, volatility of Amazon listings in the OTC space was noted, and future studies could explore whether the listings that are taken down quickly are more likely to be FDA cleared or identify other possible characteristics.
Conclusion
The OTC Hearing Aid Act has improved the accessibility and affordability of hearing devices; however, several gaps remain unaddressed. This study’s evaluation of OTC hearing aid listings on Amazon.com highlights key areas for improvement in expanding access to hearing healthcare. Specifically, efforts should focus on simplifying language to ensure readability, increasing transparency regarding FDA-clearance status, and clearly specifying the appropriate hearing loss ranges for device use. Additionally, guidance and education directed towards consumers could help them make informed decisions that suit their needs. Addressing these gaps will help ensure that OTC hearing aids effectively meet the needs of consumers while promoting informed decision-making and equitable access to hearing care.
Supplementary Material
Source of Funding:
V.M. and A.S. have funding from National Institutes of Health (NIH) and the Demant Foundation for OTC hearing aid research. A.S. has funding from Advanced Bionics Corporation for cochlear implant research. V.M. serves as scientific advisor for hearX Group (Pty) Ltd. D.W.S. has a relationship with the hearX Group (Pty) Ltd that includes equity, consulting, and potential royalties.
Footnotes
Conflicts of Interest: The remaining authors disclose no conflicts of interest.
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