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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Low Level Laser Therapy and Word Recognition in Hearing Impaired Individuals

NCT00787189

Sensorineural Hearing Loss

COMPLETED NA

Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users

NCT04242940

Bilateral Hearing Loss

TERMINATED NA

Technical Evaluation of Earswitch Phase A

NCT05784727

Motor Neuron Disease

UNKNOWN NA

Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

NCT04739436

Hearing Loss

COMPLETED NA

Investigation of Anatomical Correlates of Speech Discrimination

NCT01781039

Sensorineural Hearing Loss

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hearing Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild to severe hearing impairment

Sound amplification provided via the EarLens System assistive hearing device.

Group Type EXPERIMENTAL

Sound amplification provided via EarLens System.

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No