National Survey of Pharmacist Awareness, Interest, and Readiness for Over-the-Counter Hearing Aids

Hearing loss is a major public health concern, affecting over 30 million Americans. Few adults who could benefit from hearing aids use them. Hearing aids are now available over-the-counter (OTC) for persons with perceived mild-to-moderate hearing loss. Community pharmacies will sell OTC hearing aids to increase public access to hearing healthcare. The purpose of this study was to describe pharmacist awareness, interest, and readiness to offer OTC hearing aids at community pharmacies. A multiple-item online survey was designed using the Theory of Planned Behavior and responses were collected from licensed pharmacists from July 2021 to December 2021. Descriptive statistics were used to summarize the 97 responses collected. Most respondents were not aware of the upcoming OTC hearing aid availability. Most respondents were somewhat or very interested in increasing their knowledge on OTC hearing aids, selling OTC hearing aids, and assisting patients with OTC hearing aid selection. Most respondents disagreed or strongly disagreed that they had the necessary knowledge to counsel patients on OTC hearing aids. The most reported supporting factor was training and educational resources. OTC hearing aids are a unique public health initiative which will expand patient access to hearing health care to community pharmacies.


Introduction
Hearing loss is a major public health concern. According to data from the National Institutes of Health (NIH), 30 million Americans have hearing loss in both ears, and approximately 28.8 million adults in the United States could benefit from hearing aids [1]. Despite these statistics, fewer than 30% of adults over age 70 who could benefit from hearing aids use them [2]. When left untreated, hearing loss is associated with increased risk of depression, social isolation, falls, and dementia [3][4][5][6]. Systematic reviews indicate that hearing aids can reduce the impairment and activity limitations caused by hearing loss [7]. For these reasons, the National Institute on Deafness and Other Communication Disorders (NIDCD) has prioritized solutions to improving hearing health care to meet this urgent public health problem [8]. Offering hearing healthcare in community pharmacies is an opportunity to address this concern given that nearly 90% of Americans live within 5 miles of a pharmacy [9].
The Reauthorization Act of 2017 required the U.S. Food and Drug Administration (FDA) to create and regulate a category of over-the-counter (OTC) hearing aids for adults with perceived mild-to-moderate hearing loss. The FDA issued its final rule establishing OTC hearing aids as an approved product category on 17 August 2022 [10]. The final rule was issued concurrently with regulatory requirements that define hearing aids as a medical device regulated by the FDA, distinct from personal sound amplification devices (PSAPs) which are not regulated as medical devices. These new standards are intended to improve the accessibility and affordability of hearing aids.
Because OTC hearing aids will not require a prescription or a medical evaluation, it is likely that community pharmacists will be called upon to support safe and effective use for patients contemplating the purchase of OTC hearing aids at the community pharmacy [11]. This support may include recognizing the signs and symptoms of hearing loss, assessing the individual's need for referral, and managing patient's expectations of hearing devices after purchase [12]. However, OTC hearing aids will be self-managed devices, indicating that pharmacists will not be expected to conduct hearing tests or device fittings.
The purpose of this study is to describe pharmacist awareness, interest, and readiness to offer OTC hearing aids at community pharmacies. Understanding pharmacist awareness, interest, and readiness for OTC hearing aids serves as a first step towards maximizing pharmacists' ability to provide safe and effective supportive care to patients seeking hearing self-care at the community pharmacy.

Materials and Methods
A 28-item online survey was designed to elicit responses regarding pharmacist awareness, interest, and readiness for OTC hearing aids. The survey was administered using Qualtrics (Provo, UT) and distributed through social media and an electronic newsletter distributed by a nationwide pharmacy organization representing community pharmacists. Survey questions probed pharmacists' knowledge and interest in OTC hearing aids. Questions regarding barriers and facilitating factors were included to assess readiness. The Theory of Planned Behavior and the research framework of Dissemination and Implementation Science were used to develop survey questions [13]. Descriptive statistics were used to summarize participant demographics, knowledge and perspectives, and the constructs of awareness, interest, and readiness. We further assessed the differences in pharmacist awareness, interest, and readiness across employer or business type, practice sites, and personal hearing device use. The University of Pittsburgh Institutional Review Board approved this cross-sectional descriptive study.
Inclusionary criteria included U.S. pharmacists over 21 years of age licensed to practice. Participation was anonymous and voluntary. No compensation or incentives were provided to participants. Participants were able to stop taking the survey at any time. Prior to national distribution, the survey was piloted using a convenience sample of practicing pharmacists known to the investigators to gather feedback on survey content and design. The pilot sample was recruited through email, text messaging, and use of instant messaging on social media platforms. The pilot survey included an optional free response prompt at the conclusion of each section to elicit user feedback on survey content and navigation. Responses from the pilot were used to revise the survey structure and content in preparation for survey distribution and data collection.
The finalized survey was opened in July 2021 and responses were accepted until December 2021, after which the survey link was closed. The survey was initially distributed through a three-day advertisement in a daily email newsletter published by a national community pharmacy organization, and a second advertisement was distributed prior to the end of the recruitment period. Participants were also recruited through social media platforms, including LinkedIn, Facebook, and Reddit to broadly capture perspectives of practicing pharmacists. The survey was shared on the investigators' personal pages in addition to interest groups, pages, and forums for pharmacists on the various social media platforms. Pharmacist interest groups based in specific U.S. states were targeted to ensure the study population included participants from the Northeast, Midwest, South, and West regions of the U.S. The survey instrument collected participant age, professional experience, practice setting, and personal use of hearing devices. Additional survey questions were included to assess participant awareness of the legal status and availability of OTC hearing aids, and perceptions of the patient population served by the participant. Interests were probed through items focusing on knowledge, sale of, and resources for OTC hearing aids. To assess readiness, participant perceptions of competence, barriers, and facilitating factors to offering OTC hearing aids in a community pharmacy were also collected. Questions also explored pharmacist and employer preparation to sell OTC hearing aids, current sale of unregulated hearing devices like personal sound amplification products, and access to education and training resources during hours of employment. Lastly, participants were asked to share their concerns and perceived benefits of providing OTC hearing aids in the pharmacy. The full survey instrument is included as Appendix A.

Respondents
The survey received 97 total responses. Due to the dissemination methods, the response rate could not be determined. Eligible respondents held practice sites in 27 states, representing the Northeast, Midwest, South, and West regions of the United States [14]. Respondent demographics are summarized in Table 1.

Awareness
Of 88 respondents, 57 (64.77%) were not aware of pending OTC hearing aid availability prior to the survey. Most respondents, 48 (54.55%), stated that they were "not at all familiar" with OTC hearing aids prior to the survey. Of 87 respondents, 68.97% reported frequent interaction with persons with hearing loss who use hearing devices, while 50.57% of respondents reported interacting frequently with persons with hearing loss who do not use hearing devices. Additional data about awareness is summarized in Table 2. Fifty (67.6%) of the respondents who had never personally used a hearing device were not aware that OTC hearing aids will be available in pharmacies prior to taking the survey. Among the respondents who had used a professionally fitted hearing aid, 6 (60%) were not aware. Of the respondents who had used a personal sound amplification product, only 2 (28.6%) were not aware of OTC hearing aids.

Interest
Of 85 respondents, 94.1% were somewhat or very interested in increasing their knowledge about OTC hearing aids. Preferred education resources for OTC hearing aids from 79 respondents included continuing education (91.1%), followed by webinars (59.5%), and certificates or micro-credentials (41.8%). The majority of 85 respondents were somewhat or very interested in selling OTC hearing aids at their own practice (71.8%) and assisting patients with OTC hearing aid selection (72.9%). Pharmacist interest data is summarized in Table 3. Pharmacists employed by a mass merchant, independent pharmacy, or a traditional chain were most interested in selling OTC hearing aids at their practice. All 7 (100%) of the mass merchant pharmacists responding to "How interested are you in selling OTC hearing aids in your practice?" indicated that they were somewhat or very interested. Of the 39 independent pharmacists who responded, 34 (87.2%) were interested, and 11 (78.6%) of 14 traditional chain pharmacists were interested. Of the five respondents who stated that they were not interested in increasing their knowledge about OTC hearing aids, all (100%) stated that they were not interested in selling OTC hearing aids at their own practice and not interested in assisting patients with OTC hearing aid selection.
Respondents practicing in rural, suburban, and urban pharmacies (n = 71) reported differing levels of interest in selling OTC hearing aids. Out of 23 respondents in rural locations, 82.61% were somewhat or very interested in selling OTC hearing aids, followed by 82.35% of pharmacists in urban settings (n = 17). Of 31 respondents in suburban locations, 77.42% indicated that they were somewhat or very interested in selling OTC hearing aids. Of 17 respondents at urban sites, 58.82% agreed or strongly agreed that patients in their community would purchase OTC hearing aids, followed by 74.19% (n = 23) of 31 respondenents from suburban locations. Of 23 respondents at rural sites, 56.52% (n = 13) agreed and 21.74% (n = 5) strongly agreed that patients would purchase OTC hearing aids.
Of 7 respondents who had personally used a PSAP, 6 (85.7%) were very interested in gaining more knowledge about OTC hearing aids and 1 respondent (14.3%) was somewhat interested. All (100%) of 9 respondents who had used a professionally fitted hearing aid were either somewhat (n = 3) or very interested (n = 6) in increasing their knowledge. Of 72 respondents who had never used a hearing device, only 5 (6.94%) remained not interested in increasing their knowledge of OTC hearing aids. Additionally, 6 of 7 (85.7%) of the respondents who had used a PSAP were very interested in selling OTC hearing aids in their practice, compared to 4 of 9 (44.4%) of respondents who used a professionally fitted hearing aid and 16 of 72 (22.2%) of respondents who had never used a hearing device.

Readiness
Of 85 respondents, 59 (69.41%) agreed or strongly agreed that patients in their community would purchase OTC hearing aids at a community pharmacy. However, 57 (67.06%) of respondents disagreed or strongly disagreed that they had the necessary knowledge to counsel patients on OTC hearing aids. Of 82 respondents, 70 (85.37%) considered training and educational resources for pharmacy staff to be a supporting factor for integrating OTC hearing aids into practice, followed by professional connections to hearing healthcare professionals like audiologists 51 (62.2%) and expertise of pharmacy colleagues 49 (59.76%). The most common barriers to selling OTC hearing aids expected were pharmacist time and workflow constraints 76 (92.68%), available training and/or continuing education for pharmacists 54 (65.85%), and level of pharmacist expertise 54 (65.85%). Additional readiness data is summarized in Table 4.  Most respondents employed at traditional chains (76.92%), mass merchants (85.71%), and supermarkets (60.0%) endorsed that the decision to sell OTC hearing aids at their pharmacy was not within their control. The remainder of respondents in these categories stated they were unsure if they would offer OTC hearing aids. Respondents employed at independent pharmacies (n = 39) were the only category of respondents stating they intended to offer OTC hearing aids once available, 30.8% (n = 12). Additionally, 43.59% of 39 respondents at independent pharmacies stated that their workplace would allow time for education and training about OTC hearing aids during work hours. In contrast, only 1 (7.69%) traditional chain, 2 (2.86%) mass merchant, and 0 (0.00%) of supermarket pharmacists believed that their employer would allow time for education and training during work hours. Employer readiness is summarized in Table 5.

Discussion
OTC hearing aids represent a unique opportunity for community pharmacists to advance public health by increasing patient access to hearing healthcare. Prior to this study, little was known about pharmacist awareness, interest, and readiness to take on this new public health initiative intended to increase accessibility and affordability of hearing aids to the millions of Americans with hearing loss. To our knowledge, this is the first nationwide survey of pharmacists intended to capture pharmacist perceptions of OTC hearing aids and their intention and readiness to participate in hearing health care.
Pharmacists surveyed in this study in general lacked awareness and readiness for OTC hearing aids. Although most respondents were not aware of upcoming OTC hearing aid availability, a majority reported frequent interactions with patients who have hearing loss and use hearing devices. This discordance may further illustrate a lack of interest and engagement in hearing loss by pharmacists. Following the FDA's final ruling on OTC hearing aids, published 17 August 2022, more pharmacists and patients are likely to be aware that OTC hearing aids will be available for purchase at locations like community pharmacies. As awareness among the public increases, pharmacists and their employers should ready themselves for the sale of these products to persons with hearing loss.
Most respondents also expressed interest in learning more about OTC hearing aids, assisting patients with OTC hearing aid selection, and selling OTC hearing aids at their practice site. Pharmacist respondents who had used PSAPs indicated higher levels of interest in comparison to respondents who had never used a hearing device or who had used professionally fitted hearing aids. This may be due to the fact that PSAPs have long been available to consumers at community pharmacies without the need for a prescription or professional services. Unlike OTC hearing aids, PSAPs are not regulated by the FDA as medical devices and are not intended to treat hearing loss [11]. Respondents practicing at independent pharmacies, mass merchant pharmacies, and traditional chains had the highest levels of overall interest in selling OTC hearing aids which may indicate where OTC hearing aids will likely be sold. These pharmacy location types have experience offering medical devices to their patients including durable medical equipment, whereas supermarket pharmacies may not. Interest levels for selling OTC hearing aids were also highest among pharmacists practicing in rural and urban settings which have been found to be underserved by audiologists in a previous analysis [15]. Notably a majority of respondents at rural practice sites strongly agreed that patients would purchase OTC hearing aids from a community pharmacy. This may be due to the fact that persons in rural areas have little access to audiology services [15]. Because community pharmacies are highly accessible health care locations for the overall U.S. population, audiologists may consider establishing collaborative working relationships with pharmacists to better serve persons with hearing loss in rural areas [9,16].
There was discordance across respondents regarding the ability to offer OTC hearing aids. Most respondents at traditional chain, mass merchants, and supermarket pharmacies stated that whether or not they offer OTC hearing aids in their practice was not within their control. The remainder were unsure. Respondents at independent pharmacies were the only category that indicated an intent to offer OTC hearing aids at their practice, mostly likely due to the nature and individual control of independent ownership. Respondents at independent pharmacies frequently stated that their workplace would offer time for education and training on OTC hearing aids. This may indicate that independent pharmacies will prepare their pharmacists for OTC hearing aids by offering additional education and training.
It is relevant to consider existing literature describing pharmacist knowledge and perspectives on adopting new patient care services in pharmacy practice. A recent survey study by Nichols et al. characterized the knowledge and perspectives of community pharmacy preceptors regarding cannabidiol (CBD) approximately two years after the federal reclassification of CBD. The authors reported that more respondents were uncomfortable than comfortable counseling on CBD products, similar to our findings in the context of OTC hearing aids [17]. A second study by Smith and Rains surveyed pharmacists in Arkansas to investigate their preparedness to implement point-of-care testing services in community pharmacies [18]. A majority (52.2%) of 25 respondents in the POCT study requested additional resources beyond an initial training program. Because the majority of respondents in our study did not believe they had the necessary knowledge to counsel patients on OTC hearing aids, there exists an opportunity to provide pharmacists with additional training and continuing education resources to fill this gap. Correspondingly, a high percentage of respondents indicated that they were interested in increasing their knowledge on OTC hearing aids, and most pharmacists were interested in continuing education. However, our data suggests that extensive education and training may not be not needed to ready pharmacists for OTC hearing aids. Nearly 80% of respondents indicated that they would feel prepared to assist patients with OTC hearing aids within 6 months. Prior to this study, the University of Pittsburgh created a 2.5 h continuing pharmacy education course on OTC hearing aids which is available online for pharmacists [19].
This study is limited by the utilization of a convenience sample and by the timing of data collection. Firstly, due to convenience, the respondent sample may not comprehensively represent pharmacist awareness, interest, and readiness for OTC hearing aids despite responses from all four regions of the U.S. and a diverse profile of employers. It is also possible that pharmacists with interest in OTC hearing aids self-selected to provide responses and, as such, are overrepresented in our study. Secondly, in October 2021 the FDA released proposed OTC hearing aid regulations increasing public awareness to OTC hearing aids as a new category of hearing devices. Because regulations were proposed in the middle of our collection period (July 2021-December 2021), pharmacists who responded after may have answered differently than how they would have responded before the regulations were proposed.

Conclusions
OTC hearing aids are a unique public health initiative which will expand patient access to hearing health care to community pharmacies. Pharmacist awareness of OTC hearing aids was limited at the time of this study. Pharmacists were interested in learning more about OTC hearing aids and in assisting patients with the selection of these devices. Most pharmacists did not feel prepared to counsel patients on OTC hearing aid use. The development and dissemination of training and educational resources for pharmacists would be beneficial to the success of OTC hearing aids as a public health initiative. Informed Consent Statement: Participants were provided with an introductory script that contained basic elements of informed consent, but no formal written consent was required.

Data Availability Statement:
The data presented in this study are available on request from the corresponding author.

Acknowledgments:
The authors acknowledge the Pennsylvania Pharmacists Association Educational Foundation for their support of this research with funding. • Q12 The purpose of this research study is to assess the awareness, interest, and readiness of pharmacists regarding OTC hearing aids. For that reason, we will survey community pharmacists in the U.S. by asking them to complete a brief questionnaire that will take approximately 10 min. All participants must be 21 years of age or older. If you are willing to participate, our questionnaire will ask about your background (e.g., age, years practicing as a pharmacist, practice setting and location), as well as about your knowledge and views regarding OTC hearing aids. There are minimal foreseeable risks associated with this project (e.g., discomfort answering survey questions.) There are no direct benefits to you. This is an anonymous questionnaire, and your responses will not be identifiable in any way. All responses are confidential, and results will be stored electronically in password-protected files.  (6) Informal personal research (7) On-the-job training (8) Webinars (10) Other (please specify) (11) _____________________________________________ • Q64 Does your place of work currently sell any assistive hearing devices such as hearing aids, personal sound amplification products (PSAPs), assisted listening devices, or hearables?

Conflicts of Interest
Yes (please specify) (1) ________________________________________________ No (2) Unsure (3) Not applicable (5) • Q19 Will your place of work allow time for your education and training regarding OTC hearing aids during work hours?
Yes (1) No (3) Unsure (2) Not applicable (4) • Q37 Do you intend to offer OTC hearing aids as a service in your pharmacy once these products are available?
Yes (1) No (2) Unsure (3) Not in my control (5) Not applicable (4) • Q36 If OTC hearing aids were available today, when would you feel prepared to assist patients with these devices?
Within 30 days (1) Within 6 months (2) Within 1 year (3) After 1 or more years (4) I do not intend to offer OTC hearing aids at my pharmacy (7) Not applicable (8) • Q39 What benefits do you see to offering OTC hearing aids at the pharmacy? (Select all that apply) Flexible treatment options for persons with hearing loss (7) Improved patient access to hearing aids (2) Increased patient interest in the use of hearing aids (1) Increased revenue at my place of employment (3) Reduction of health risks associated with hearing loss (4) Other (5)