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

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