RP401 - A New Frontier in Extended-Wear Hearing

Abstract:
Extended-wear hearing aids are not a new concept; however, self-replacement, an exciting new approach to managing extended-wear hearing aid patients, has been studied and cleared for clinical use. Join us for this session to understand the safety and effectiveness outcomes of this multi-center clinical study, involving fifty-seven subjects across 7 clinical sites. Additionally, see how this new procedure can provide increased options and satisfaction to providers and their patients by minimizing the burden of repeated in-office visits for device replacement.

Extended-wear hearing aids are worn continuously in the external auditory canal for months at a time. However, they require periodic device replacement, approximately once every 4-6 weeks, which can be burdensome to Hearing Care Providers (HCPs) and patients. This clinical investigation was conducted to evaluate the effectiveness and safety outcomes between the extended wear self-replacement procedure and the current standard of care, the HCP-replacement procedure. Study data support the expanded indication for use known as self-replacement, allowing eligible patients to periodically replace their own devices under the direction and care of their HCPs.

Fifty-seven experienced extended-wear hearing aid users were enrolled across 7 sites in this prospective, non-randomized clinical investigation. The single cohort of subjects followed a self-controlled study design, where repeated measures were used to investigate effectiveness and safety across three instances of replacement under each replacer condition (self, HCP). The co-primary effectiveness endpoints were non-inferiority of Aided Audiometric Threshold testing and Aided Speech-in-Noise testing (QuickSIN) for the self-replacement procedure versus the HCP-replacement procedure. Safety was continuously monitored throughout the study, comparing outcomes between the self- and HCP- HCP-replacement procedures.

After passing the HCP-guided self-replacement candidacy assessment and in-person training, study participants alternated between HCP-replacement and self-replacement approximately every two weeks for a total of three replacements in each condition. Unscheduled study visits outside of the pre-determined study visit schedule were incorporated for device issues and ear health management on an as-needed basis. Due to the anticipated learning effect, non-inferiority of effectiveness endpoints was evaluated based on a comparison of the third instance of Self-replacement versus HCP-replacement. When comparing the self-replacement procedure with the HCP-replacement procedure, non-inferiority was achieved for both co-primary effectiveness endpoints. Aided Audiometric Thresholds at 500, 1000, 2000, and 4000 Hz were tested, and differences between self- and HCP-replacement outcomes averaged between -0.5 to 1.5 dB HL for left ears and -0.69 to 0.89 dB HL for right ears, with p-values < .0001. Aided Speech-in-Noise testing, measured using the average SNR Loss scores of two QuickSIN lists, averaged 0.10 dB for left ears and 0.46 dB for right ears, with p-values < .0001. No systematic differences were observed in safety outcomes between the two replacement procedures throughout the study.

To establish non-inferiority, the burden of responsibility defined in the clinical investigation included the achievement of effective outcomes for right and left ears separately, in two distinct measures: aided speech-in-noise testing and aided audiometric thresholds. Data collected in this study met and exceeded this burden of responsibility, and observation of safety data revealed no meaningful differences in safety outcomes between the self-replacement and HCP-replacement methods.

The results of this study highlight one of the biggest innovations in extended-wear hearing aids since they entered the market over 15 years ago. This new procedure allows clinicians and patients to benefit from reduced clinic visits, allowing for more efficient use of clinic time and improved satisfaction for extended-wear hearing aid users. In addition, this new procedure provides extended-wear hearing aid users peace of mind and comfort by providing the user with a back-up extended wear device.