Clinical trial NCT02042404: The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Official title: The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Impairment
Keywords: Hearing impairment
Hearing loss
Lead sponsor: EarLens Corporation
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 48
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 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:

  1. an abnormal tympanic membrane
  2. an abnormal middle ear or history of prior middle ear surgery other than tympanostomy tubes
  3. 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:

  1. history of chronic and recurrent ear infections in the past 24 mouths
  2. history of dizziness and/or vertigo in the past 24 months
  3. taking medications/treatments with known ototoxic effects
  4. a rapidly progressive or fluctuating hearing impairment
  5. 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

Primary outcomes:
measure: Change in Mean Aided Word Recognition Scores (WRS) When Compared to the Baseline Unaided Condition.
timeFrame: Baseline and 30 days
measure: Audiometric Safety as Shown by no Hearing Change Pre and Post Treatment
timeFrame: Baseline and 120 days
Secondary outcomes:
measure: Functional Gain Over the Frequency Range From 2000 to 10,000 Hz
timeFrame: Baseline and 30 days
measure: Change in Aided HINT 90 Speech Reception Thresholds (SRTs) When Compared to the Baseline Unaided Condition.
timeFrame: Baseline and 30 days
Other outcomes:
measure: Determine the Incidence of Serious Device- and Procedure-related Adverse Events.
timeFrame: 120 days
Locations:
city: Menlo Park
country: United States
facility: EarLens Corporation
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 Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa Dept of Otolaryngology--Head and Neck Surgery University of Iowa Hospitals and Clinics
name: Bruce Gantz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: EarLens Corp.
name: Sunil Puria, Ph.D.
role: STUDY_CHAIR
References:
citation: Fay JP, Perkins R, Levy SC, Nilsson M, Puria S. Preliminary evaluation of a light-based contact hearing device for the hearing impaired. Otol Neurotol. 2013 Jul;34(5):912-21. doi: 10.1097/MAO.0b013e31827de4b1.
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.