PP424 - Reliability of Electroacoustic Performance in Lucid Engage Over-the-Counter Devices

Abstract:
In 2022, the FDA approved the sale of over-the-counter (OTC) hearing aids without a prescription with the goal of improving adults’ access more affordable treatment options. OTCs are purchased without a check of the electroacoustic parameters as is typical of devices delivered by audiologists. The goal of this study was to determine the reliability and validity of electroacoustic measures in a set of OTC receiver-in-the-canal hearing aids. The data indicate that the measurements are generally reliable but do not accurately reflect changes in the user controls or meet manufacturer’s specifications, highlighting the importance of the audiologists’ role in device fitting.

Summary:
With the FDA approval of over-the-counter (OTC) hearing aids, there are many questions that arise regarding the performance of OTC hearing aids. The availability of these devices removes the need for audiology services in the process of device fitting. Verification methods used by audiologists, such as electroacoustic analysis and simulated speech mapping, can provide valuable insight on device function. For this project, Twelve Lucid Engage hearing aids were electroacoustically evaluated for various degrees of hearing loss to determine reliability, agreement with real-ear targets, and consistency with manufacturer’s specifications. The study measures coupler reliability, electroacoustic performance, and speech performance of each device and utilizes the acoustic variables that consumers can change via the Lucid Hearing App. The app has four settings: Mild, Moderate, Bass Boost, Max. It has an additional feature called Lucid Shape that allows for basic frequency-specific gain adjustments. A Verifit II and ANSI 3.22-2009 standards were utilized in this project. Part I of the study was an initial reliability test was performed where electroacoustic analysis was run 10 times on a single hearing aid to ensure coupler reliability. For Part II, each of the 12 devices was then measured. Devices were set to the Max program and full volume to simulate full-on-gain. Initial contact with the manufacture revealed consumers cannot place devices in manufacturer settings for electroacoustic analysis. In Part III of the study, test-box speech mapping was run on each device at soft, average, and loud speech and speech intelligibility index (SII) was measured. A standard A23 audiogram and Adult NAL-NL2 prescription was used among the devices. Each device was run in the Mild, Moderate, Bass Boost, Max settings, sequentially. They were then run at maximum volume. The final setting utilized Lucid Shape feature so that 2000-4000 Hz could be adjusted to maximum gain. Electroacoustic analysis and speech mapping results revealed measurements are generally reliable within and across devices. While there is consistency in output in electroacoustic analysis, devices did not accurately reflect changes in the user controls and were unable to meet manufacturer’s published specifications. These results suggest the need for further research into OTC device performance and indicate the need for audiologists and the importance of verification measures in device fittings. These results also indicate that consumers cannot assume that the devices they are purchasing perform as intended.