Audiologists Opinions on OTC

During the first week of August, 2017, the Hearing Health and Technology Matters (HHTM) blog conducted a survey of subscribers. The purpose of the survey was to explore the views of audiologists on the subject of Over-The-Counter (OTC) hearing aids. A total of 566 audiologists, based in the United States, completed the survey. Readers of Audiology Practices are encouraged to read the entire survey. Some of the key findings are summarized in the infographic.

In an effort to bring more clarity to the OTC debate, Garrett Thompson, a recent graduate from the City University of New York and a former winner of the annual ADA business competition, weighs in by reviewing many of the recent studies that have examined the provision of OTC devices. Audiologists are encouraged to stay abreast of the OTC debate by critically examining all aspects of the discussion. In addition to Dr. Thompson’s interpretation of current research, readers can seek out other systematic reviews, such as the recent Audiology Online webcasts conducted by Dr. Vinaya Manchaiah of Lamar University and Nicholas Reed of John Hopkins University.

A Cute Baby Dressed Like a Turtle and the Evidence for OTC Disruption
Author: Garrett Thompson, Au.D.

Many a concerned post, tweet, text, and conversation has been had regarding the over-the-counter (OTC) hearing aid bill that passed this Congress. After considering the evidence, I am happy to report that the sky is not falling. I’ll explain later, but for now believe me when I say OTCs will NOT have a huge disruptive impact on our profession, and they may even bring more attention to audiology than has ever been seen in the past. Not all of it will be good attention, but as the adage goes: any publicity is good publicity (if you shape it the way you want). There will be great change in our future, and with that some discomfort, but it’s nothing we cannot overcome. Perseverance is shown to be more predictive of success than almost any other attribute, including intelligence; in these anxious times, if we show some perseverance and develop a strategic plan, I believe audiology will not only survive the OTC wave, we will in fact thrive.

This is a cute baby dressed-up like a turtle. You’re welcome.

This is an actual turtle. This is also a metaphor. This turtle has sensed a threat and has turtled in his turtle shell. His evolutionary fight-or-flight response kicked in and he picked flight (an internal flight, but flight nonetheless).

When it comes to the OTC hearing aid discussion, most audiologists (justifiably) sense a threat approaching. As best as I can tell, most audiologists’ reaction to this threat expresses itself as two primary fears:

Fear #1 Our patients will be hurt by OTC hearing aids.

Fear #2 OTCs will replace audiologists.
Don’t get me wrong, both fears are rational. But if we unpack them slightly, I think they are less ominous than at first glance.

Fear #1 is legitimate and benevolent. I agree that there will be some examples of bad results from people self-diagnosing and self-treating hearing loss. Yet, this is already happening with PSAPs that are all over the shelves and Internet. In fact, during the April, 2017 Federal Trade Commission (FTC) workshop on hearing healthcare, Frank Lin argued that the Warren/Grassley bill increases regulation of a wild-west PSAP market. This increase in regulation will protect more patients from harm.

The following argument appears in the literature as well: it is said that the direct-to-consumer hearing aid market is, at this time, highly unregulated and unsupported by evidence-based data (Keidser & Convery, 2016). Some argue that this law will draw massive attention to OTCs and thus more negative cases (harm to patients) would result. The key point to consider here is that a group of unimpeachable experts (the PCAST and NAS working groups) made a public health cost/benefit analysis and decided that the societal benefit of helping tens of millions of people access affordable hearing healthcare outweighs the small number of poor outcomes. If you disagree with that, it’s your prerogative to do so, but you should know that that is what and who you are disagreeing with. It should be noted that Senators Warren and Grassley followed the experts’ recommendations nearly to the T.

In terms of Fear #2, it’s slightly less legitimate and slightly less benevolent. Let’s cut to the chase and take a look at the evidence, both for the efficacy of OTCs and the patient perceptions of self-managed care. Only a handful of studies have evaluated an OTC or OTC-like hearing aid intervention, let’s take a look:
Study #1
In a placebo-controlled double-blind randomized clinical trial, Humes et al. (2017) investigated the efficacy of hearing aid intervention in older adults comparing three delivery methods: a traditional audiology best practices (AB) model, a consumer decides (CD) model, and a placebo. The CD model is related to an OTC model, in that the consumer manages the process on her own with no involvement from a professional, but it likely does not actually emulate a OTC consumer process that would exist in the real world. The Hume et al study was performed in a clinical setting, where the CD group watched an instructional video and was provided a booklet on the self-fitting process, at which time they were allowed to trial as many as six hearing aids to determine which of three amplification profiles they preferred. The hearing aids were pre-loaded with four programs of varying gain configurations, of which the participant could self-adjust via volume control after the selection session, if necessary. Although there are similarities to a potential OTC model, the fact that participants could trial up to six devices is likely not realistic for purchasing an OTC device. The CD group was thoroughly tested and monitored in a clinical setting, which could have affected the perception of success of the CD process. Additionally, 42% of potential participants were rejected because they did not meet the mild-to-moderate hearing loss and no middle ear problems selection criteria; in the real world this group would likely not remove themselves from OTC consideration. As several of these factors are not typical of the way OTC hearing aids are currently dispensed, the generalizability of this study is somewhat limited.

Participants in this study were 154 adults 53-83 years old with mild to moderate, bilateral, symmetrical, sensorineural hearing loss (SNHL), with no previous experience with hearing aids. Baseline testing was performed before and outcomes measures were obtained at the end of the six week trial. Outcome measures included the Hearing Handicap Inventory for the Elderly (HHIE), the Connected Speech Test (CST), the Profile of Hearing Aid Performance (PHAPglobal), and the Hearing Aid Satisfaction Survey (HASShaf). High-end digital mini-BTE (behind-the-ear) hearing aids were used for all participants. For the placebo group, the HAs were programmed to a zero dB insertion gain acoustical transparence, meaning they provided no amplification for average inputs, probably because of their input compression circuitry added 6-8 dB of gain for soft inputs. For the AB and CD groups, basic features were enabled including: directional microphones, dynamic feedback suppression, and noise reduction. In the AB group, HAs were programmed to the NAL-NL2 prescriptive formula and matched to targets using Real Ear Measure verification (Humes, et al, 2017).

Results revealed that the AB model was significantly better than the CD model for improvement in HHIE, PHAPglobal, and HASShaf. Both the AB and CD models were efficacious, meaning they each showed significant benefit relative to the unaided condition in terms of HHIE, PHABglobal, HASShaf, and CST scores. The authors point out that the CD model yielded only slightly poorer effect sizes than the AB group. Interestingly, even though the placebo intervention was not statistically better than the unaided scores, 39% of participants expressed a desire to keep the placebo devices (Humes, et al, 2017).
Study #2
An earlier pilot study directly compared a simulated OTC model with a traditional hearing healthcare delivery model of care (Tedeschi & Kihm, 2016). This study was designed to determine if individuals can properly self-diagnose and classify their hearing loss, as well as how satisfied they will be with an OTC model and how it compares to the traditional model. A sample of 29 individuals with self-reported mild-to-moderate hearing loss who are not using HAs or PSAPs were given the opportunity to choose one of several PSAPs that are commercially available. For six weeks they used these devices without professional involvement. Prices of the PSAPs that were offered ranged from $100-$450. Following that period, those who had hearing loss were invited to receive audiology best practice (ABP) intervention for another six weeks which included: a hearing evaluation, counseling, fitting and verification of hearing aids, instructional information, and aftercare services as needed (Tedeschi & Kihm, 2016). Ultimately, 18 individuals participated in this second phase. The design of this study was intended to mimic the sequence of a typical OTC consumer, moving from self-treatment to professional treatment, even if not in a realistic timeline. However, because the study was not counter balanced; that is, every study participant followed the same treatment sequence (OTC followed by professional care), the order of treatment may have had an effect on the study results.

The authors note that of the 29 participants, four of them (13%) were referred to an ENT due to medical or audiological contraindications for hearing aid use; three of these individuals were eventually cleared for hearing aid use and participated in the study. In each phase of the study, participants were asked to evaluate the process twice. To the question of accurate self-diagnosis, 15 of 29 (52%) correctly identified their hearing as mild-to moderate; of those who did so incorrectly, three had normal hearing and eleven had poorer than moderate hearing. Furthermore, only 14 of 29 (48%) correctly identified their hearing loss as unilateral or bilateral.

When comparing the two delivery models in terms of levels of usage, 95% of the ABP group used the devices at least a few times a week; in the OTC group 59% of participants used them at least a few times a week. After the six week period, satisfaction with ABP was considerably higher than for OTC devices; 83% were at least somewhat satisfied compared to 48% for the OTC model. One in three of the ABP group were very satisfied, in the OTC group that number was one in ten. However, 52% of participants reported that the OTC device helped at least some of the time and they would recommend one to a friend; the willingness to recommend hearing aids to a friend is highly correlated to satisfaction (Kochkin, 2007). Also of note is that at the end of the OTC phase, 90% of participants felt that having some assistance from a professional would have been at least somewhat useful when getting used to the device. (Tedeschi & Kihm, 2016).
Study #3
Kochkin (2014) conducted a large survey of traditional hearing aid (THA) users and direct-mail (DM) hearing aid users. In total, 1,721 THA users and 2,332 DM completed the 7-page survey. The THA sample was drawn from Kochkin’s (2012) MarkeTrak VIII data, and the DM sample were customers of the largest US direct-mail hearing aid firm (Kochkin, 2014). The samples include individuals with a range of hearing loss configurations, income, and education levels; all participants were adults. DM hearing aids were not programmed to the hearing test of an individual, but rather were pre-programmed with amplification profiles that fit the most common hearing losses; this is somewhat analogous to an OTC consumer experience. The THA group was also broken into deciles based on the level of audiology best practices (BP) they received, where BP1 is a minimal hearing aid fitting protocol, BP10 is a comprehensive hearing aid fitting protocol, and BP5 is the median (Kochkin, 2014).

Results of the survey revealed that both THA and DM hearing aids were efficacious in that they both improved listening performance in various situations and quality of life (QOL) (Kochkin, 2014).
Figure 3. Quality of Life Changes Attributed to Hearing Aid Use, Comparing Direct-Mail and Traditional Hearing Aid Fittings Ranked by Best Practices (Kochkin, 2014)

As seen in Figure 3, 46% of DM users perceived either “better” or “a lot better” QOL. For the THA group, the level of best practices greatly impacted the improvement in QOL. Audiology services at or below the median BP decile produced no better QOL improvement than the DM delivery model; BP5 resulted in “better” or “a lot better” QOL in 39% of subjects, less than the 46% produced by DM. The most comprehensive fitting protocol, however, resulted in “better” or “a lot better” QOL in 75% of subjects, significantly higher than the DM users.

As a measure of value, Kochkin calculated the dollars spent for each percentage-point reduction in hearing handicap.
Figure 4. Value of Device Purchase, Expressed as Median Dollars Spent for Each Percentage-Point Reduction in Hearing Handicap (Kochkin, 2014)

As seen in Figure 4, DM users perceived higher value in the devices than the THA group as a whole and higher than even the most comprehensive BP service. Although the overall hearing handicap reduction was less than the THA model, because the cost was significantly less, the value of DM aids was greater (Kochkin, 2014).
Figure 5. Overall Consumer Success with Hearing Aids as a Function of Value, Comparing Direct-Mail and Traditional Hearing Aid Fittings Ranked by Best Practices (Kochkin, 2014)

Figure 5, above, graphically displays consumer success as a function of value for each of the BP deciles and the DM aids. The results reveal that a DM model of hearing aid delivery is moderately successful and has high value, while a comprehensive traditional fitting protocol (BP10) is highly successful and has moderate value. A median fitting protocol (BP5) leads to the same level of success as DM but delivers dramatically less value to the patient/consumer. Overall, Kochkin (2014) found that patient satisfaction was highly driven by perceptions of value.
Study #4
Convery et al. (2016) sought to evaluate the performance of individuals as they attempted the complete process of self-fitting a hearing device. Mimicking the framework of an OTC experience, they used a commercially available product (SoundWorld Solutions RIC-style HA). The sample was comprised of 40 adults aged 50-88 years with mild to moderately-severe sensorineural hearing loss, half of which were experienced and half inexperienced hearing aid users; 24 participants brought a family member for assistance, as needed. Participants followed a set of written and illustrated instructions to perform the multi-step fitting procedure, and success was determined by whether they could complete the entire task (Convery et al., 2016).

Results revealed that 55% of participants were able to successfully complete the self-testing and self-fitting task. This is similar to the 58% of participants that were able to complete audiograms for both ears using in-situ audiometry in an earlier study by the same authors (Convery et al., 2015). Although success versus failure in this study (Convery et al., 2016) was based exclusively on the seven-step testing and fitting process, it should also be noted that only 16 participants (40%) were able to successfully navigate the process of pairing the devices to the tablet which was necessary for hearing testing and fitting (Convery et al., 2016). Interestingly, the individuals who received help from a family member were no more likely to complete the task than those who didn’t. There was also no difference in success rate between the experienced and inexperienced group, although the types of mistakes differed between groups (Convery et al., 2016). The most frequent failure was due to poor insertion of the RIC earpiece in the ear, success on this task was 77%; this is consistent with previous data from these researchers in which success rates for insertion were previously found to be 58% (2011) and 77% (2015). The authors note that participants who made mistakes in the self-fitting process were generally unaware that they had done so.
Japanese Model
An important model to study on a national scale is the hearing aid market of Japan, where OTC devices are readily available in retail stores, on the Internet, and via mail order (Hougaard et al., 2013). In one particular study (Hougaard et al., 2013) hearing aid uptake was the lowest of all developed countries, 14% compared to an average of 35% in France, Germany, the United Kingdom, and the United States. Additionally, only 39% of hearing aid users were satisfied with their devices, compared to approximately 80% in the other developed countries (Hougaard et al., 2013). However, who is to say what the results will be in a model that offers both conventional and OTC hearing aids? Could these OTC users add to the ones that are already using the traditional model? Cultural difference between West and East also play a confounding role in trying to analyze these data, as views on aging and disability are quite different.

As the patients will ultimately decide if they want to engage with an OTC device at some point along their journey, it is essential to consider the evidence about perceptions of OTCs. Here’s what we know so far:
Patient Perception Study #1
A recent survey (Plotnick & Dybala, 2017) of 809 adults was conducted to assess their opinion of a potential OTC hearing aid. The sample was adults aged 50 years and older, geographically and socioeconomically diverse, and most had little experience with hearing aids; this is thought to be emblematic of the market interested in low cost OTC hearing devices. The results indicated that 93.8% of survey respondents considered the involvement of a hearing care professional in the selection, fitting, and programming of a hearing aid to be either very important or absolutely important. Interestingly, 95.3% of respondents were only willing to spend $200 or less on an OTC hearing aid (Plotnick & Dybala, 2017). On the whole, consumers understand the potential benefits of direct-to-consumer hearing aids, but they also express reservations and a preference for the involvement of an audiologist (Kochkin, 2014; Chandra & Searchfield, 2016; Plotnick & Dybala, 2017).
Patient Perception Study #2
In a semi-structured interview survey of 18 older adults (Chandra & Searchfield, 2016), the perception of internet-purchased HAs is mixed. Most participants were unaware that hearing aids can be purchased online. When the process was described to them, several themes emerged from participants’ responses. They recognized potential benefits of purchasing aids online, such as perceived lower cost and increased convenience and physical accessibility. There were reservations, though, including whether and how clinical procedures would be performed in the assessment and fitting of hearing aids; procedures noted were hearing evaluation, fine-tuning of hearing aids, and physical ear mold modifications (Chandra & Searchfield, 2016). Participants also conveyed a general distrust of online retailers, which included a lack of trustworthiness, a lack of trust in the brand of hearing aid, and a fear of scammers. Several participants stated that they preferred involvement of an experienced professional in the hearing aid fitting process, and they considered this type of expert advice and support to not be available in an online retail framework (Chandra & Searchfield, 2016).
Patient Perception Study #3
Similar results were found in a survey asking 80 older adults about their perception of a hearing aid which is self-fit without the involvement of an audiologist (Convery et al., 2011). Participants noted potential benefits such as increased convenience and the ability to self-adjust the device, however they also expressed a preference for professional guidance through the fitting process. About half of the participants responded affirmatively to all three of the following: that a self-fitting aid was a good idea, that it would be of personal benefit, and that it could be managed independently by the user (Convery et al., 2011).

The way I interpret these data is that OTC devices will produce mixed results, helping a sizeable proportion of customers, but leaving many others unsatisfied. From the relatively limited evidence that exists, the proportion of successful OTC consumers, characterized as those that are at least somewhat satisfied or have at least moderate improvement in QOL, ranges from 39-58% (Hougaard, 2013; Kochkin, 2014; Convery et al., 2015; Convery et al., 2016; Tedeschi & Kihm, 2016; Humes et al., 2017). For individuals that are successful with the devices, OTCs represent a high value product that may improve hearing, reduce the handicap associated with hearing loss, and increase quality of life (PCAST, 2015). This represents a public health boon that audiologists should support. However, although OTCs provide reasonable benefit and great value, an overwhelming majority of patients have reservations about self-care and still want a professional to be involved in the process (Convery et al., 2011; Kochkin, 2014; Chandra & Searchfield, 2016; Plotnick & Dybala, 2017). OTCs may be a reasonable self-treatment option, used in conjunction with professional collaboration, for the vast majority of people with mild-to-moderate hearing loss who do not seek treatment from the traditional hearing healthcare delivery model.

Although they have the potential to make a positive public health impact, OTC devices have significant weaknesses and don’t fix non-cost-related reasons why people don’t wear hearing aids. The legislation and OTC devices themselves fail to overcome the stigma associated with wearing hearing aids or the difficulties that individuals in the target market have with dexterity problems, among other shortcomings. The focus on OTC devices fails to address the importance of family and community support networks and self-management of hearing loss in difficult listening situations (Hogan et al., 2015).

In the fight-or-flight decision over OTC hearing aids, the obvious choice is fight. Ironically, I don’t mean fight the legislation or fight change in general. I mean fight the urge to give up. Anyone suggesting that OTCs will take down our profession is implicitly saying that our knowledge and skills can be replaced by a device and a CVS clerk. To that I say: come at me bro. I find that sentiment to be utterly ridiculous, and the evidence clearly suggests that patients want a professional’s involvement in the hearing aid process. Future-thinking audiologists should see OTCs as an opportunity, and they should be prepared to augment the hearing healthcare of both satisfied and unsatisfied OTC users. For patients who are experiencing success with OTC devices, audiologists have a role in objectively documenting their status and adding value via counseling, real ear measures, speech in noise testing, and validation questionnaires. For OTC users who are not satisfied with their devices, the audiologist has a role in improving their performance and introducing them to services and devices that may provide more benefit including aural rehabilitation, hearing assistive technologies, and traditional hearing aids.

In a more general sense, the future will bring more change to our profession, not less. If we think every threat will end us, and our strategy is to be discouraged and run away, then this will become a self-fulfilling prophecy. One example of this I have seen is people explicitly discouraging potential audiology students from joining the profession. I’m all for giving people the whole truth and letting them decide for themselves, but in my opinion this recommendation, and this attitude in general, is a much greater threat to the profession than OTC devices.
The OTC conversation has stirred the pot tremendously, but I hope the information presented in this article will calm some nerves. In my opinion OTCs will not trivialize our profession, and they will help (to some degree) millions of people who have previously not engaged with hearing healthcare. As audiologists, our core mission is to help people communicate better, not to help them communicate better with hearing aids, on our terms. We should be excited to help people hear better regardless of whether the technology we employ is via an app, OTC, hearing aid, cochlear implant, or even hair cell regeneration. Let’s keep working to improve all the things that an audiologist brings to the table, such as personal adjustment counseling to overcome the maladaptive behaviors brought on by years of untreated hearing loss, and the ability to customize both the physical and acoustic fit of any device that goes into, around or near the ear.

Garrett Thompson, Au.D. is a private practice audiologist at Resnick Audiology in New York City. His interests include hearing aid technology, telehealth, and tinnitus management. He completed his residency at the Callier Center of UT-Dallas and graduated from the City University of New York. His writing has previously been featured in Audiology Today and Thompson received a BA in Economics from Boston College. Contact him at or @Dr_Audball.

Excerpts of this article first appeared at the Hearing Healthcare and Technology Matters blog who granted permission to reprint it here.
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