The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
1 other identifier
interventional
48
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
February 2, 2016
CompletedFebruary 2, 2016
January 1, 2016
10 months
January 20, 2014
August 17, 2015
January 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Functional Gain Over the Frequency Range From 2000 to 10,000 Hz
Baseline and 30 days
Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.
Baseline and 30 days
Other Outcomes (1)
Determine the Incidence of Serious Device- and Procedure-related Adverse Events.
120 days
Study Arms (1)
Mild to severe hearing impairment
EXPERIMENTALSound amplification provided via the EarLens System assistive hearing device.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
EarLens Corporation
Menlo Park, California, 94025, United States
Camino Ear Nose and Throat Clinic
San Jose, California, 95138, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Related Publications (2)
Fay JP, Perkins R, Levy SC, Nilsson M, Puria S. Preliminary evaluation of a light-based contact hearing device for the hearing impaired. Otol Neurotol. 2013 Jul;34(5):912-21. doi: 10.1097/MAO.0b013e31827de4b1.
PMID: 23524632BACKGROUNDArbogast TL, Moore BCJ, Puria S, Dundas D, Brimacombe J, Edwards B, Carr Levy S. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019 May/Jun;40(3):741-756. doi: 10.1097/AUD.0000000000000661.
PMID: 30300158DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Suzanne Levy, Director of Clinical Research
- Organization
- EarLens Corporation
Study Officials
- 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.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2014
First Posted
January 22, 2014
Study Start
March 1, 2014
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
February 2, 2016
Results First Posted
February 2, 2016
Record last verified: 2016-01