The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
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|ClinicalTrials.gov Identifier: NCT02042404|
Recruitment Status : Completed
First Posted : January 22, 2014
Results First Posted : February 2, 2016
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hearing Impairment||Device: Sound amplification provided via EarLens System.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||March 2015|
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.
- Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. [ Time Frame: Baseline and 30 days ]Change 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, expressed as a percentage of words correct, 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 device placement.
- Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment [ Time Frame: Baseline and 120 days ]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 (Pure Tone Average at 4 frequencies; 500, 1000, 2000, and 4000 Hz) will be computed both for baseline unaided hearing pre-placement and unaided hearing post-removal for each ear, then averaged across both ears for each subject . 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: Baseline and 30 days ]10 dB (decibel) change in the averaged pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, 9000 and 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. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds.
- Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. [ Time Frame: Baseline and 30 days ]Change 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). An improvement in HINT score is indicated as a negative (-) dB value change. A more negative value indicating an improvement of understanding speech and noise. An improvement of -1dB is equivalent to a 10% improvement in understanding speech and noise and is likely of clinical benefit. HINT 90 will be measured twice and averaged to obtain the per subject HINT SRT. All subject data will be averaged to obtain the means. Analysis includes calculation of the unaided measurements (before device placement) minus the aided measurements.
- Determine the Incidence of Serious Device- and Procedure-related Adverse Events. [ Time Frame: 120 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02042404
|United States, California|
|Menlo Park, California, United States, 94025|
|Camino Ear Nose and Throat Clinic|
|San Jose, California, United States, 95138|
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|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.|