Clinical trial NCT02470494: The EarLens Contact Hearing Device (CHD) Spectrum Study
Official title: The EarLens Contact Hearing Device (CHD) Spectrum Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Sensorineural
Lead sponsor: EarLens Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hearing Stability Using Unaided Air Conduction Thresholds.
timeFrame: Baseline and up to 90-day.
Secondary outcomes:
measure: Change in Speech Understanding in Noise.
timeFrame: Baseline and up to 90-day.
measure: Change in Functional Gain Over the Frequency Range From 2000 to 10,000 Hz.
timeFrame: Baseline and up to 90-day.
measure: Change in Subject's Self-Perceived Ability to Communicate.
timeFrame: Baseline and up to 90-day.
Other outcomes:
measure: Adverse Events
timeFrame: Baseline and up to 90-day.
Locations:
city: La Jolla
country: United States
facility: California Hearing and Balance Center
state: California
city: Menlo Park
country: United States
facility: Rodney Perkins Associates
state: California
city: San Jose
country: United States
facility: Camino Ear Nose and Throat Clinic
state: California
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Marrero
country: United States
facility: CNC Hearing and Balance Center
state: Louisiana
city: Raleigh
country: United States
facility: Carolina Ear and Hearing Clinic
state: North Carolina
city: Pittsburgh
country: United States
facility: Pittsburgh Ear Associates
state: Pennsylvania
city: San Antonio
country: United States
facility: Ear Medical Group
state: Texas
Study officials:
affiliation: EarLens, Corp.
name: Brent Edwards
role: STUDY_DIRECTOR
References:
citation: Arbogast TL, Moore BCJ, Puria S, Dundas D, Brimacombe J, Edwards B, Carr Levy S. Achieved Gain and Subjective Outcomes for a Wide-Bandwidth Contact Hearing Aid Fitted Using CAM2. Ear Hear. 2019 May/Jun;40(3):741-756. doi: 10.1097/AUD.0000000000000661.