NCT02470494

The EarLens Contact Hearing Device (CHD) Spectrum Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: EarLens Corporation · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Detailed description

The study is designed to obtain observational data and as such no primary safety or efficacy endpoints or sample sizes are computed. Information gathered about device utility and clinic procedures from the physician, audiologist as well as subject questionnaires will be analyzed for the purpose of optimizing the process flow in different types of practice settings. A subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be collected and adverse events will be tracked and reported per applicable regulations.

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DEVICE	Sound amplification provided via the EarLens CHD	Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.

Timeline

• Start date: 2015-06-01
• Primary completion: 2016-06-01
• Completion: 2016-11-01
• First posted: 2015-06-12
• Last updated: 2017-06-27
• Results posted: 2017-06-27

Locations

8 sites across 1 country: United States