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

NACompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

January 31, 2015

Study Completion Date

March 31, 2015

Conditions
Hearing Impairment
Interventions
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.

Trial Locations (3)

52242

University of Iowa Hospitals and Clinics, Iowa City

94025

EarLens Corporation, Menlo Park

95138

Camino Ear Nose and Throat Clinic, San Jose

Sponsors
All Listed Sponsors
lead

EarLens Corporation

INDUSTRY