Important Randomized, Placebo-Controlled, Study Sheds Light on OTC Delivery Model

otc hearing aid delivery model study
March 7, 2017

As most know, accessibility and affordability of hearing aids is a hot button issue of national importance. On March 3, for example, the Journal of the American Medical Association Internal Medicine posted a summary of the issue surrounding over-the-counter hearing aids on their website. Authored by Senators Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Massachusetts) the article makes clear the Senators plan to “make good on the FDA’s promise and take important steps to fix a broken market for hearing aids.”

In an open access article on the ASHA website one important piece of information further illuminates the issues of access and affordability. Using a randomized, double-blind, placebo-controlled (RCT) trial, which is considered the highest standard of clinical research, Indiana University (IU) professor Larry Humes and his colleagues published their findings last week in the American Journal of Audiology.


Hearing Aid Outcomes Study: First of Its Kind in Industry


Larry Humes, PhD

Dr. Humes and colleagues examined 154 adults between the ages 55–79 years with mild-to-moderate, medically uncomplicated hearing loss. Participants, who were all inexperienced users of amplification, received the same bilaterally fitted mini open-canal hearing aids. All participants received a complete audiologic evaluation prior to their enrollment into one of three groups.

The participants were randomly divided into three groups:  One group received “audiology best practice” services delivered by the IU audiologists. These best practices included professional fitting and counseling using published best practice protocols. The second group received no professional fitting by an audiologist and selected their own pre-programmed hearing aids. This group, which received their hearing aids via an over-the-counter (OTC) method, was referred to in the study as the consumer decides (CD) group. The third group, known in the study as the placebo group, received a professionally fitted pair of hearing aids, but they were programmed to provide no acoustical benefit. Additionally, the purchase price of the hearing aids for all three groups was manipulated with roughly half them receiving their hearing aids for a “typical” purchase price of $3600 per pair and the other half receiving them for the “reduced” price of $600 for both hearing aids.

Humes and his colleagues found that hearing aids were effective in older adults for both the “audiology best practices” model and the “consumer decides” OTC model. There were no significant differences in outcome between these two service-delivery approaches for five of the six outcome measures used in the study. The OTC group fared somewhat worse on some device-centric measures of satisfaction. Both the “audiology best practices” and “consumer decides” groups outperformed the placebo group on all measures of outcome.

Further, according to the findings, fewer OTC participants were likely to purchase their hearing aids after the initial six week trial (55% for the OTC group vs. 81% for the “audiology best practices” group, compared to 36% for the placebo group).


Following the initial 6-week trial, both the OTC and placebo groups were offered hearing aids under the audiologist-driven best practices model. Satisfaction significantly increased for patients in both groups who chose to continue under audiologist care, and more participants opted to purchase their hearing aids after this continued period of care than after the initial trial.


Clinical Implications of Study


There are several clinical implications that can be gleaned from this randomized, double-blind, placebo-controlled (RCT) trial.


  1. It is the first-ever placebo-controlled double-blinded randomized control study (a very high standard of evidence) that indicates hearing aids are effective for older adults with medically uncomplicated, bilaterally symmetrical mild to moderate hearing loss. Both the OTC and “audiology best practice” groups derived superior outcomes relative to the placebo group.
  2. Although the specific OTC delivery model employed in this study required the participants to obtain an audiological assessment and medical clearance prior to participating in the study, the results indicate both the OTC delivery model used in the study and an audiology best practices model yielded similar beneficial results.  Thus, the type of OTC delivery process used in this study is a feasible method for obtaining hearing aids for some adults.
  3. Following the initial 6-week trial, a higher number from the OTC group were likely to return their hearing aids. But after given the opportunity to participant in another 4-week follow-up trial under the direction of an audiologist, all but two of the participants decided to keep their hearing aids. This result indicates the value of the professional to the process by which some individuals achieve a successful fit.
  4. Purchase price (at the $600 and $3600 price points) had no effect on outcomes, although a higher percentage of those at the $3600 price point returned their devices at the end of the trial.


As Humes told ASHA is a recent press release, “More studies are needed to assess the generalization of the results obtained here to other patient populations, other devices, and other models of OTC service delivery. However, the results of this study should serve as a yardstick for comparing outcomes of future hearing aid studies.”


*featured image courtesy wisegeek

  1. The so-called “important study” found at is fatally flawed from the outset by including only those “with medically uncomplicated hearing loss”. Who decides that a given case is “medically uncomplicated” under that OTC Delivery Model? Without the current FDA regulation, which has withstood the test of time and everyday practice, there is really no one left to determine who needs and who does not need medical attention.

    Another major flaw is that although it purports to be a “double blind: study, it biases consumer opinion by dividing them into two price point strata, $600 per device and $3600 per device. Several problems arise here:

    1) Only a tiny handful of hearing aid offices in the US charge $3600 per device–so it misrepresents the true average cost of appropriately fitted hearing aids which currently stands at about $1495, not $3600,

    2) One can obtain good, basic hearing aids for $600 each from most dispensers in the US according to a recent statewide survey in Arizona,

    3) The study pretends the cost of the hearing aids reflects just the hardware itself,

    4) Thereby completely disregarding the essential and added value services of the professional dispenser,

    5) And does not measure important aspects of dispensing, such as own voice effects, spatial ability, comfort, dexterity, and ongoing servicing considerations and the expert counseling that goes with it.

    I will repeat some of my earlier treatise on the topic of PCAST/PSAPs here and hope our members are getting aboard the fight to persuade the powers that be that the Grassley/Warren bill and all those being quietly introduced to state legislatures throughout the US that these proposals are NOT good for consumers–and take away current needed consumer protections.These proposals will NOT increase accessibility nor lower real costs. No healthcare product and service in the US is more accessible than hearing aid dispensing products and services. Competitive forces keep costs under control as they should. Besides, cost and accessibility are not even anywhere near the top of the list of reasons hearing impaired individuals are not wearing hearing aids.

    The PCAST/PSAP recommendations, if implemented, will be extraordinarily harmful to hearing impaired consumers. The industry that has worked so hard to bring about the many consumer protections built into today’s hearing health system and licensing laws that are not available in any other healthcare area.

    Furthermore, past studies have shown again and again that most hearing impaired individuals perceive their loss to be “mild” or “mild to moderate”. Hence, unsuspecting consumers will be unwittingly drawn to inferior devices and services without anyone being required to refer them for medical and/or audiological care when needed. Without professional guidance, case history taking, counseling, appropriate and safe impression taking, programming and tests for verification, own-voice problem resolution, and technical services consumers will be left in the cold and develop a far worse impression of hearing aids, in general.

    It is simply egregious to build recommendations on the false premise that accessibility and cost are holding back a market that is actually in denial. Study after study demonstrates that cost is NOT a prominent or leading barrier, but instead lack of awareness, consumer education, and the psychological & psychosocial aspects related to long standing hearing loss. Besides, most dispensers have no cost or low cost programs that help those truly in need but without personal resources.

    It is critical to note that the fatal flaws to PCAST recommendations are thus:

    1) Doing away with the FDA 8 Red Flags and medical exam (and waiver) requirement will effective decouple the Otolaryngologist from the hearing health team on the majority of the hearing impaired market. This will present serious public health threats reminiscent of the pre-1977 rules and regulation.

    2) Proliferation of unlicensed and unqualified individuals to sell hearing aids will subject hearing impaired consumers to misfitted devices that do will meet their needs, and will fail to refer them for medical and other care when indicated.

    3) Requiring licensed practitioners, who stand to suffer dramatic loss of business, to provide a free copy of their hearing test so that it can be taken to unlicensed competitors is unfair competition and detrimental to consumers on several levels. In short, the current network of licensed dispensing professionals will be so badly disrupted as to leave uncountable hearing aid users without the technical and counseling support system they now enjoy.

    I urge all to reject these poorly conceived proposals. They were instigated without input or approval from the hearing aid profession. They ignore the psychosocial and immensely complex components of loss of human hearing, and will leave consumers with less access to quality care and support services, and will effectively demolish the carefully developed Hearing Health Care Teams that now serve every community of the United States.

    The link to the IHS Website to contact your Congressman/woman and Senators is found at There, you can email each of them and also print out a copy to mail snailmail. I suggest doing both.

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