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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.
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Must not have known or active medical issues that would preclude having a device including:
Must not have other known or active medical issues including:
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
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Interventional model
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48 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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