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Amplification and Assistive Devices (AAD)

Assessing the Impact of the FDA’s OTC Hearing Aid Regulations: A Survey of User Experience and Perception of OTC Self-Fitting Hearing Aids

PP303 - Assessing the Impact of the FDA’s Over-the-Counter (OTC) Hearing Aid Regulations: A Survey of User Experience and Perception of OTC Self-Fitting Hearing Aids

POSTERS
Location: Halls A1-A2
Instructional Level: Fundamental
Abstract:
In 2022, the US Food and Drug Administration issued final regulations to establish a category of over-the-counter (OTC) hearing aids. One year post-enactment, progress toward more widespread adoption of hearing aids and perspectives from OTC users are not well understood.  We will review survey results from users of one company’s self-fitting OTC devices, which offer insight into users’ experience and how a direct-to-consumer delivery and support model may be helping to achieve the intent of OTC regulations. Survey responses suggest improved: adoption time, accessibility, perceived affordability, destigmatization, and competition and innovation while continuing to validate the efficacy of OTC devices.

Summary:

Rationale/

Purpose:
The rationale of this study lies in the desire to understand the progress made in the adoption of hearing aids and OTC user perspectives in the time following the enactment of the 2022 FDA OTC regulations. We hypothesize that the availability of self-fitting OTC hearing aids provided by a direct-to-consumer delivery and support model may help to facilitate the fulfillment of the FDA’s intent behind OTC regulations. To investigate this, we analyzed survey results from users of one company’s OTC devices aiming to shed light on users’ experiences and determine whether there have been improvements in factors such as adoption time, accessibility, affordability, destigmatization, and competition/ innovation, while continuing to validate the efficacy of OTC devices.

Methods:
Customers of a single company who had purchased a set of self-fitting OTC hearing aids between October 17, 2022 and May 31, 2023 were surveyed. There were 884 non-incentivized, anonymized respondents. The questions asked in this survey were intended to aid in understanding whether the direct-to-consumer business model was helping to improve hearing aid access, advancing the aims of the FDA regulations. The OTC process completed by these users is as follows: respondents independently purchased devices via the internet or phone and completed self-fitting using a mobile phone app. 

Results/

Conclusions:
Survey results showed that self-fitting OTC hearing aids help provide benefits sought by the FDA. Key findings include decreased adoption time compared to established literature values (~4 years versus 8.9 years, respectively); a significant number of first-time users choosing OTC devices (70%); recognition of key benefits of the direct-to-consumer channel (convenience, transparent costs, speed, competitive technology); recognition of key barriers in the traditional channel (multiple in-person visits, types of hearing aids available, appointment wait time); the decreased stigma of device use (cosmetically appealing form factor), and high perceived affordability of OTC devices (only 3% of users felt OTC devices are less affordable). Of particular interest to clinical audiologists is the perspective and motivation of users who switched from the traditional channel to the OTC channel. 67% of all survey respondents had been seen for an in-person hearing exam with a hearing care professional, increasing to 76% for users under 65. Additionally, 30% of respondents had used traditional hearing aids prior. Of this subset, we saw the comparative effectiveness of OTC versus traditional devices: 75% reported OTC devices were better than or equal to traditional; 87% reported the process of getting devices was quick and efficient (46% for traditional), and 83% of users reported that using and maintaining OTC devices was equal to or easier than traditional devices.
This survey demonstrates that certain OTC hearing aids and service-delivery strategies may positively impact adoption time, accessibility, perceived affordability, destigmatization, competition, and innovation. For audiologists working clinically, this data may help to inform the rationale of a patient's decision-making when choosing an OTC device versus a traditional device. Continuing to encourage consumer-centric innovation in technology and service-delivery models may deepen the impact of the OTC regulations and help to minimize the prevalence of untreated hearing loss in years to come.

Learning Objectives:

  • List key motivations for a patient to become an OTC user including barriers to the traditional hearing care pathway and advantages to the OTC pathway