The EarLens Contact Hearing Device (CHD) Spectrum Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.

Conditions

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Hearing Loss, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sound amplificatoin via EarLens CHD

Sound amplification provided via the EarLens CHD for subjects with hearing impairment.

Group Type EXPERIMENTAL

Sound amplification provided via the EarLens CHD

Intervention Type DEVICE

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

Interventions

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Sound amplification provided via the EarLens CHD

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 to 85 years.
2. Mild to severe hearing impairment between 125 to 8000 Hz.
3. Asymptomatic of retro-cochlear lesions or cleared of retro-cochlear lesion by MRI.
4. 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)
5. Greater than or equal to 50% on clinical speech discrimination demonstrating an ability to benefit from amplification;
6. 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
7. Experience with 1 or 2 air conduction hearing aids or previously evaluated for use with hearing aids;
8. Fluent speaker of American English due to use of American English study materials

Exclusion Criteria

1. 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.
2. Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 50 and 56

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No