N/A
N=46
The EarLens Contact Hearing Device (CHD) Spectrum Study
Hearing Loss, Sensorineural
Bottom Line
View on ClinicalTrials.gov: NCT02470494 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Hearing Stability Using Unaided Air Conduction Thresholds. — -0.5 dB difference in Unaided Hearing
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sound amplification provided via the EarLens CHD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EarLens Corporation
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hearing Stability Using Unaided Air Conduction Thresholds. |
-0.5 | — |
| SECONDARY Change in Speech Understanding in Noise. |
2.0 | — |
| SECONDARY Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz. |
27.2 | — |
| SECONDARY Change in Subject's Self-Perceived Ability to Communicate. |
29.0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 85 years.
- Mild to severe hearing impairment between 125 to 8000 Hz.
- Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
- No significant conductive hearing impairment;
- No more than a 10 dB air-bone gap at 3 of 4 tested frequencies (500, 1000, 2000, or 4000 Hz)
- Normal Type A tympanometry (indicating normal mobility of the tympanic membrane and middle ear bones)
- Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
- Able and willing to commit to the travel and time demands of the study (available for 5 months or longer) and able to comprehend and comply with the study materials and instructions
- Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
- Fluent speaker of American English due to use of American English study materials
Exclusion Criteria
- The Subject must not have known or active medical issues that would preclude having a hearing device, including:
- an abnormal TM (deemed perforated, inflamed or has a dimeric or monomeric area, or in any other way abnormal);
- an abnormal middle ear or a history of prior middle ear surgery other than tympanostomy tubes;
- an ear canal anatomy that prevents the physician from seeing an adequate amount of the tympanic membrane.
- an anatomical configuration of the external auditory canal that prevents satisfactory placement of the TMT
- a history of chronic and recurrent ear infections in the past 24 months;
- a rapidly progressive or fluctuating hearing impairment;
- diagnosed with having a compromised immune system which may impact the tissue of the auricle or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or received radiation of the head ever or chemotherapy for cancer within the last six years.
- Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56
Data sourced from ClinicalTrials.gov (NCT02470494). 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.