The EarLens Contact Hearing Device (CHD) Spectrum 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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.

Detailed Description
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The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.

Official Title
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The EarLens Contact Hearing Device (CHD) Spectrum Study

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Device: Sound amplification provided via the EarLens CHD


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 8000 Hz. Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI. No significant conductive hearing impairment; No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz) Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones) Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification; Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids; Fluent speaker of American English due to use of American English study materials Exclusion Criteria: The Subject must not have known or active medical issues that would preclude having a hearing device, including: an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal); an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes; an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane. an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT a history of chronic and recurrent ear infections in the past 24 months; a rapidly progressive or fluctuating hearing impairment; diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

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: Sound amplificatoin via EarLens CHD<br>Sound amplification provided via the EarLens CHD for subjects with hearing impairment. | Device: Sound amplification provided via the EarLens CHD<br>* Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hearing Stability Using Unaided Air Conduction Thresholds. | Hearing sensitivity was monitored using earphones with the TMT (Tympanic Membrane Transducer) in place, but with the audio processor removed. Baseline and study end measurements were compared. A PTA4 (Pure Tone Average at 4 frequencies; 500, 1000, 2000 and 4000 Hz) was computed both for baseline unaided hearing post-placement with TMT in place, and unaided hearing with TMT in place at the 90-day for each ear, then averaged across both ears for each subject. A determination of No Hearing Change for the subject was made if the calculated hearing changes of the subject population are 10dB or less. | Baseline and up to 90-day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Speech Understanding in Noise. | The change in aided speech reception thresholds (SRTs) when compared to the baseline unaided condition was measured using a validated speech test, the HINT 90. Change in aided HINT 90 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. | Baseline and up to 90-day. | 
| Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz. | 10 dB (decibel) change in the average pure tone thresholds for the subject population over the frequency range from 2000 to 10,000 Hz (2000, 3000, 4000, 6000, 8000, and 10,000 Hz). Measurement to be used in analysis are the baseline unaided soundfield (SF) thresholds measured prior to device placement and the aided soundfield thresholds measured 90-day post placement. Analysis includes calculation of the unaided soundfield thresholds minus aided soundfield thresholds | Baseline and up to 90-day. | 
| Change in Subject's Self-Perceived Ability to Communicate. | The change in the subject's self-perceived ability to communicate with the use of the EarLens Device (CHD) when compared to baseline condition was measured using the validated Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire. The APHAB produces scores for 4 subscales: Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV), which all range from 0-99%. A global score is computed by averaging the EC, RV, and BN subscores. For an individual score (either unaided alone or aided alone), a higher number indicates poorer performance, or more difficulty experienced. For this outcome measure, the difference between the average of the global unaided and aided scores is computed to determine the reduction (if any) in self-perceived difficulty, so a larger number in this outcome measure indicates better performance, as more of the difficulty has been reduced from the unaided condition by going to the aided condition. | Baseline and up to 90-day. |