The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

Study Overview
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Brief Summary
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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.

Official Title
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The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

Conditions
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Hearing Impairment

Intervention / Treatment
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* Device: Sound amplification provided via EarLens System.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 85 years Mild to severe hearing impairment between 125 to 4000 Hz No significant conductive hearing impairment Able and willing to commit to travel and time demands of the study Exclusion Criteria: Must not have known or active medical issues that would preclude having a device including: an abnormal tympanic membrane an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes an ear canal anatomy that prevents physicians from seeing adequate amount of the tympanic membrane Must not have other known or active medical issues including: history of chronic and recurrent ear infections in the past 24 mouths history of dizziness and/or vertigo in the past 24 months taking medications/treatments with known ototoxic effects a rapidly progressive or fluctuating hearing impairment having been diagnosed with having a compromised immune system Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56 Must not have an ear canal anatomy that preclude manufacture of the device as determined by EarLens manufacturing personnel

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild to severe hearing impairment<br>Sound amplification provided via the EarLens System assistive hearing device. | Device: Sound amplification provided via EarLens System.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. | 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. | Baseline and 30 days | 
| Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment | 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. | Baseline and 120 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Gain Over the Frequency Range From 2000 to 10,000 Hz | 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. | Baseline and 30 days | 
| Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. | 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. | Baseline and 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing impairment, Hearing loss