The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
The EarLens System is an assistive hearing device that is intended to provide amplification for the treatment of patients with sensorineural hearing impairment. The purpose of this multi-center definitive study is to assess the safety and efficacy of the EarLens System for subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully activated system in their daily lives for a 4 month period of time. This study is designed to support US and International marketing applications to commercialize the EarLens System. The main efficacy hypothesis is that the EarLens System will be shown to improve speech understanding in quiet.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study|
- Improvement in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. [ Time Frame: At least 30 days ] [ Designated as safety issue: No ]Improvement in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition. WRS will be measured using 50-word NU-6 (Northwestern University Auditory Test No.6) recorded materials, presented at 45 dB Hearing Level on a per-ear basis with the test ear isolated for measurement and the results averaged across the two ears for each subject. All subject data will then be averaged to obtain the means. The baseline unaided measurements will occur prior to device placement, and the aided condition will be measured at least 30 days post placement.
- Audiometric safety as shown by no hearing change pre and post treatment [ Time Frame: At least 120 days ] [ Designated as safety issue: Yes ]The unaided air conduction hearing thresholds will be measured for each individual ear twice before device placement at Visit #1 and averaged to obtain the baseline unaided air conduction hearing thresholds, and the post wear unaided air conduction hearing thresholds will be measured after device removal at Visit #5. A PTA4 (500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal. A determination of "No Hearing Change" for the subject population will be made if the calculated Hearing Changes of the subject population are 10 dB or less.
- Functional gain over the frequency range from 2000 to 10,000 Hz [ Time Frame: At least 30 days ] [ Designated as safety issue: No ]10 dB (decibel) improvement in thresholds for the subject population over the frequency range from 2000 to 10,000 Hz. Measurement to be used in analysis are the baseline unaided soundfield thresholds measured prior to device placement and the aided soundfield thresholds measured at least 30 days post placement.
- Improvement in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. [ Time Frame: At least 30 days ] [ Designated as safety issue: No ]Improvement in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition. SRTs will be measured using HINT materials with the signal (speech level presented from 0 degrees) adapted relative to the noise (presented from 90 degrees held fixed at 60 dB SPL) to determine the signal-to-noise ratio for reporting the whole sentence correct 50% of the time (Nilsson et al., 1994). HINT 90 will be measured twice, once with the noise 90 degrees to the right and once with the noise 90 degrees to the left; the SRTs will be averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. The baseline unaided measurements will be made prior to device placement, and the aided condition will be measured at least 30 days post placement
- Determine the incidence of serious device- and procedure-related adverse events. [ Time Frame: At least 120 days ] [ Designated as safety issue: Yes ]The analysis of the incidence of serious device- and procedure-related adverse events through the study period. All adverse events will be recorded on case report forms and determinations will be made as to the whether the events are related to the investigational device.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||February 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Mild to severe hearing impairment
Sound amplification provided via the EarLens System assistive hearing device.
Device: Sound amplification provided via EarLens System.
The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02042404
|Contact: Suzanne Levy, Ph.D.||email@example.com|
|Contact: Tanya Arbogast, Sc.D.||firstname.lastname@example.org|
|United States, California|
|Menlo Park, California, United States, 94025|
|Contact: Tanya Arbogast, Sc.D. 650-366-3636 email@example.com|
|Principal Investigator: Rodney Perkins, M.D.|
|Camino Ear Nose and Throat Clinic||Recruiting|
|San Jose, California, United States, 95138|
|Contact: Jennifer Tucker, Au.D. 408-227-6300 firstname.lastname@example.org|
|Principal Investigator: Michael Murray, M.D.|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Camille Dunn, Ph.D. 319-353-8776 email@example.com|
|Principal Investigator: Bruce Gantz, M.D.|
|Principal Investigator:||Bruce Gantz, M.D.||University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics|
|Study Chair:||Sunil Puria, Ph.D.||EarLens Corp.|