This trial is active, not recruiting.

Condition hearing impairment
Treatment sound amplification provided via earlens system.
Sponsor EarLens Corporation
Start date April 2014
End date June 2015
Trial size 50 participants
Trial identifier NCT02042404, EarLens CRP00004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Sound amplification provided via the EarLens System assistive hearing 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.

Primary Outcomes

Improvement in mean aided Word Recognition Scores (WRS) when compared to the baseline unaided condition.
time frame: At least 30 days
Audiometric safety as shown by no hearing change pre and post treatment
time frame: At least 120 days

Secondary Outcomes

Functional gain over the frequency range from 2000 to 10,000 Hz
time frame: At least 30 days
Improvement in aided HINT 90 speech reception thresholds (SRTs) when compared to the baseline unaided condition.
time frame: At least 30 days

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Principal investigator Bruce Gantz, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by EarLens Corporation.