Statistical analysis completed by Amyn M. Amlani, Ph.D.
Despite a lack of experience with PSAPS, audiologists are leery of their effectiveness compared to conventional hearing aids.
Personal sound amplification products, or PSAPs, have gotten a lot of attention recently from the media and federal regulators, not to mention the many venture capitalists funding new PSAP companies. Noting lower costs and improving performance of these unregulated products, they wonder whether PSAPs might be an easier and more affordable solution than hearing aids for the more than 30 million Americans with untreated hearing loss.
When Hearing Tracker surveyed audiologists about PSAPs, learning that many have a low opinion of PSAPs was not a surprise. Dispensing audiologists make most of their income by fitting their patients with hearing aids, which are expensive by comparison. Any movement to make PSAPs easier to acquire as a solution for hearing loss could be a potential threat to their livelihood.
But a deeper look into the data reveals that respondents had very limited experience in dealing with patients who had previously experimented with PSAPs. Which leaves another question open for future surveys: will audiologists eventually find a way to co-exist with the burgeoning unregulated market for low-end PSAPs, or will more familiarity with them simply breed more contempt?
To Regulate or De-regulate?
The federal Food and Drug Administration (FDA), does not classify PSAPs as medical devices. Instead, PSAPs are “hearing enhancement” products that can be purchased over-the-counter for prices ranging from under $50 to more than $350. According to the FDA, which issued its most recent guidelines in 2013, PSAPs are intended to be used by adults with normal hearing who desire listening enhancement for specific recreational situations, such as birdwatching. Under the guidelines, PSAPs are not to be called “hearing aids” or promoted as a solution for hearing loss. Unlike hearing aids, which are governed by a different set of FDA rules, issued in 1977, PSAPs can be purchased without receiving a hearing test from a licensed professional.
PSAPs have been available for several years, and with incremental improvements in miniaturized technology, some now function similarly to conventional hearing aids. Responding to ongoing complaints about the accessibility and affordability of traditional hearing aids, consumer electronics companies and consumer advocacy groups have started to put tremendous pressure on the FDA from to update the regulations of hearing aid and PSAPS. One government advisory group recently recommended that a new category of direct-to-consumer, unregulated “basic” hearing aids be created.
Hearing instrument manufacturers and clinical professionals are among the groups benefiting most from the current hearing aid regulations, so it should be no surprise that they are, with a few exceptions, vehemently opposed to any changes in FDA regulations that would make amplification devices available directly to consumers. But dozens of PSAPs are currently on the market, with anecdotal reports suggesting many individuals with hearing loss are purchasing them instead of traditional hearing aids. Hearing Tracker’s survey of audiologists is an initial effort to learn more about their attitudes and beliefs with respect to PSAPs. Following are the baseline results which we can use to compare with future survey responses.
Limited PSAP Experience—So Far
In April, 2016, Hearing Tracker invited audiologists to take part in a survey entitled “PSAPs and Your Practice.” The invitation was posted in private audiology groups on Facebook and LinkedIn and generated 143 responses within 24 hours. Chart 1 shows the breakdown, as a percentage, of the practice setting best describing each respondent.
Practice Location of Respondents
Chart 1. Practice location of respondents, expressed as a percentage of total numbers of respondents. Category “Other” includes university clinic, VA hospital, etc.
Question 2 of the survey asked respondents to approximate the percentage of patients seen in their practice that have tried PSAPs prior to their visit in their respective clinic. On a scale between 0% (no patients have tried PSAPs) and 100% (all patients have tried them), the mean was 13%, with a range of scores between 0 and 70%. Just three of the 143 respondents provided a response to Question 2 higher than 45%.
Questions 3 through 6 on the survey asked respondents to rate on a 1 to 5 Likert scale (Figure 1) the following:
- How often patients seek information about PSAPs
- How often patients ask whether they should try PSAPs
- If a patient has sought an adjustment for a PSAPs purchased elsewhere
- How often the respondent has recommended a PSAP
Answers to Questions 3 through 6 suggest that the overwhelming majority of clinicians encounter a relatively small number of patients seeking information about PSAPs, with fewer than 10% of respondents providing a rating of either 4 or 5 on any of the questions. A mean rating of around 2 would seem to indicate clinicians infrequently interact with patients who use PSAPs. Further, responses to Question 9, which asked respondents how often they recommended PSAPs, indicated just two of them (1.5%) recommended PSAPs relatively frequently.
Question 7 asked respondents to indicate on a 1-5 Likert scale how satisfied their patients were with PSAPs. The mean score was 1.6, with just two (1.5%) of the respondents providing a rating of 4 or 5 on the scale. In contrast, Questions 8 and 9 queried respondents about perceived benefit and satisfaction of hearing aids by prior owners of PSAPs. The mean score for Question 8, how much hearing improvement do prior PSAP owners typically experience when fitted with conventional hearing aids, was 3.7, and similarly for Question 9, how much more satisfied are prior PSAP wearers when fitted with conventional hearing aids was 4.0. The mean scores for these two questions indicate that most respondents believe the products they prescribe and fit result in superior performance relative to PSAPs.
Interestingly, the survey results indicate that audiologists working side-by-side with physicians (in hospitals and ENT settings) advocate PSAPs more so than audiologists working in private practice settings. Audiologists in private practice reported a greater “hearing improvement” when fitting PSAP-users with conventional hearing aids. Perhaps the need to deliver the best possible hearing outcome in private practice settings has led audiologists to avoid recommending PSAPs all together. Another possibility is that audiologists in private practice settings are more dependent on the sale of hearing aids to generate revenue. A third and final possibility: Could it be that physicians themselves are stronger proponents of PSAPs, thus driving increased advocacy of the technology by the audiologists they employ?
Questions for the Future
These survey results showed a strong negative opinion about PSAPs among audiologists. At the same time, however, only a small percentage of respondents indicated any extensive experience with patients who had tried PSAPs. Those that had helped patients migrate from PSAPs to programmable hearing aids reported very high patient satisfaction with the upgrade. This was especially the case in private practice settings, as discussed above.
These findings raise numerous questions for future surveys, including two obvious ones: Are PSAPs, though low cost, still so inferior to more expensive custom-programmed hearing aids that people with hearing loss who try them get very little help from them? Or are PSAP buyers so happy with the hearing enhancement they are getting that they never bother to visit an audiologist in the first place? A third question to explore: Why are audiologists in medical settings recommending PSAPs at a higher rate than their peers in private practice?
With these baseline findings, Hearing Tracker is planning future surveys of its growing network of audiologists. As the PSAP market develops, and especially as regulators decide whether to make PSAPs easier to buy as a solution for hearing loss, the surveys should help provide perspective on how big an impact PSAPs will ultimately have on delivery of hearing health services to consumers with hearing loss.
About Brian Taylor
Brian Taylor, AuD is the senior director of clinical affairs for Turtle Beach. He is also the clinical audiology advisor for Fuel Medical Group, Camas, WA. He can be contacted at firstname.lastname@example.org
About Amyn M. Amlani, Ph.D.
Dr. Amlani is an Associate Professor on the faculty of the Department of Speech and Hearing Sciences, University of North Texas. Dr. Amlani holds the B.A. degree in Communication Disorders from the University of the Pacific, the M.S. degree in Audiology from Purdue University, and the Ph.D. degree in Audiology/Psychoacoustics (minor in Marketing and Supply Chain Management) from Michigan State University. His research interests include the influence of hearing aid technology on speech and music, and economic and marketing trends within the hearing aid industry.
Last modified: June 2, 2016