CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Sound amplification provided via the EarLens CHDdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02470494
NCT02470494N/ACompleted
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The EarLens Contact Hearing Device (CHD) Spectrum Study

EarLens Corporation·interventional·Posted Jun 12, 2015·Updated Jun 27, 2017

In Brief

A clinical study evaluating Sound amplification provided via the EarLens CHD for Hearing Loss, Sensorineural. Completed, enrolled 46 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Loss, Sensorineural
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 12, 2015
Enrollment StartJun 1, 2015
Primary CompletionJun 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 11.1 years ago

Interventions

Sound amplification provided via the EarLens CHDdevice

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