The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study

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.

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