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The EarLens Contact Hearing Device (CHD) Spectrum Study

NCT02470494 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2017-06-27

Study results available
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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 the proposed study (Extended Investigation under the Continued Access Policy) is to continue to allow access to the investigational medical device with the collection of device utility and clinic process-flow data while the marketing application is under review at the FDA.

Conditions

  • Hearing Loss, Sensorineural

Interventions

DEVICE

Sound amplification provided via the EarLens CHD

Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.

Sponsors & Collaborators

  • EarLens Corporation

    lead INDUSTRY

Principal Investigators

  • Brent Edwards · EarLens, Corp.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-06-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02470494 on ClinicalTrials.gov