N/A
N=48
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Hearing Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02042404 ↗Enrolled (actual)
48
Serious AEs
10.4%
Results posted
Feb 2016
Primary outcome: Primary: Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. — 37.6 percentage of words correctly identified — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sound amplification provided via EarLens System. (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EarLens Corporation
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition. |
37.6 | <0.0001 sig |
| PRIMARY Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment |
-0.3983 | <0.0001 sig |
| SECONDARY Functional Gain Over the Frequency Range From 2000 to 10,000 Hz |
30.4819 | <0.0001 sig |
| SECONDARY Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition. |
0.7542 | 0.0281 sig |
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 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.
Eligibility Criteria
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:
- an abnormal tympanic membrane
- an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
- 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:
- history of chronic and recurrent ear infections in the past 24 mouths
- history of dizziness and/or vertigo in the past 24 months
- taking medications/treatments with known ototoxic effects
- a rapidly progressive or fluctuating hearing impairment
- 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
Data sourced from ClinicalTrials.gov (NCT02042404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.