Last synced on 25 November 2022 at 11:04 pm

Wireless Earlens Light Driven Hearing Aid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153634
510(k) Type
Traditional
Applicant
EARLENS CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/6/2016
Days to Decision
110 days
Submission Type
Statement

Wireless Earlens Light Driven Hearing Aid

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K153634
510(k) Type
Traditional
Applicant
EARLENS CORPORATION
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/6/2016
Days to Decision
110 days
Submission Type
Statement