The EarLens Contact Hearing Device (CHD) Spectrum Study

Completed · Not applicable

Conditions studied: Hearing Loss, Sensorineural

In brief

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.

Key facts

Study ID

NCT02470494

Run by

EarLens Corporation

People needed

46

Starts

2015-06-01

Expected to finish

2016-11-01

Last updated by the study team

2017-06-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Hearing and Balance Center — La Jolla, California, United States
• Rodney Perkins Associates — Menlo Park, California, United States
• Camino Ear Nose and Throat Clinic — San Jose, California, United States
• University of Iowa — Iowa City, Iowa, United States
• CNC Hearing and Balance Center — Marrero, Louisiana, United States
• Carolina Ear and Hearing Clinic — Raleigh, North Carolina, United States
• Pittsburgh Ear Associates — Pittsburgh, Pennsylvania, United States
• Ear Medical Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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