Abstract:
Over-the-counter hearing aids have been available to consumers in the US since 17 October
2022 following a ruling by the Food and Drug Administration. However, their reception by hearing
healthcare professionals (HHP) has been mixed, and concerns have been expressed by many HHPs.
The aim of this study was to examine the concerns that HHPs have towards over-the-counter (OTC)
hearing aids. The study used a retrospective survey design. The survey data of HHPs (n = 730)
was obtained from Hearing Tracker. A 22-item structured questionnaire was administered using
a Question Scout platform. Descriptive analyses examined reported areas of concern and a Fisher’s
exact test examined the relationship between demographics and responses. A cluster analysis with
partitioning around medoids (PAM) was used to identify a sub-group of participants based on
responses. Nearly half of HHPs who participated reported that they will support patients with OTC
hearing aids purchased elsewhere, whereas a quarter reported that they will sell OTC hearing aids
in their clinic or website. HHPs expressed over 70% agreement in ‘concern’ statements in 14 of the
17 items. Issues about safety, counseling, and audiological care were the key concerns expressed
by HHPs about OTC hearing aids. Some demographics (i.e., profession, primary position) were
associated with responses to some statements. Two groups were identified based on the responses to
concern statements. The HHPs in the first cluster ‘OTC averse’ (51%) agreed on all the 17 concern
statements, whereas the second cluster ‘OTC apprehensive’ (49%) had some items rated as disagree
(i.e., consumers will give up on amplification) and neither agree nor disagree (i.e., do not provide
good value, warranties and return periods will be worse), and remaining items were rated as agree.
OTC hearing aids were initiated to improve affordability, accessibility, and hearing aid uptake and
are currently a rapidly emerging category of hearing devices. Overall, the results of the current
study indicate that HHPs have serious concerns about OTC hearing aids. HHP concerns cited in this
study provide useful feedback to stakeholders (e.g., HHP professional agencies, FDA, industry, and
insurance payers) involved in improving OTC hearing aid implementation.
Description:
INSTITUTIONAL REVIEW BOARD STATEMENT : This study was conducted in accordance with Declaration
of Helsinki, and approved by the institutional review board (Reference number 02606623-
HUM007/0922) at the University of Pretoria, South Africa on 26 October 2022 for studies involving
human subjects.
DATA AVAILABILITY STATEMENT : The data presented in this study are available upon request from the corresponding author. The institutional policy is that a formal data-sharing agreement is required to share the data with outside researchers.