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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by EarLens Corporation
Sponsor:
Information provided by (Responsible Party):
EarLens Corporation
ClinicalTrials.gov Identifier:
NCT02042404
First received: January 20, 2014
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Hearing Impairment
Device: Sound amplification provided via EarLens System.

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by EarLens Corporation:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

    1. an abnormal tympanic membrane
    2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
    3. 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:

    1. history of chronic and recurrent ear infections in the past 24 mouths
    2. history of dizziness and/or vertigo in the past 24 months
    3. taking medications/treatments with known ototoxic effects
    4. a rapidly progressive or fluctuating hearing impairment
    5. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042404

Contacts
Contact: Suzanne Levy, Ph.D. 650-366-9000 slevy@earlenscorp.com
Contact: Tanya Arbogast, Sc.D. 650-366-3636 tarbogast@earlenscorp.com

Locations
United States, California
EarLens Corporation Recruiting
Menlo Park, California, United States, 94025
Contact: Tanya Arbogast, Sc.D.    650-366-3636    tarbogast@earlenscorp.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    dr.tucker@caminoent.com   
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    camille-dunn@uiowa.edu   
Principal Investigator: Bruce Gantz, M.D.         
Sponsors and Collaborators
EarLens Corporation
Investigators
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.
  More Information

Additional Information:
Publications:
Responsible Party: EarLens Corporation
ClinicalTrials.gov Identifier: NCT02042404     History of Changes
Other Study ID Numbers: EarLens CRP00004
Study First Received: January 20, 2014
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by EarLens Corporation:
Hearing impairment
Hearing loss

Additional relevant MeSH terms:
Deafness
Hearing Loss
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014