meddevicedb.com FDA Device Reference

Bose Hearing Aid

DEN180026 Class II Direct
Decision Date
2018-10-05
Sponsor / Applicant
Bose Corporation

Technical Specification

510(k) Submission ID DEN180026
Product Code QDD
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.3325
Decision Date 2018-10-05
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Bose Hearing Aid received FDA 510(k) clearance under submission number DEN180026, sponsored by Bose Corporation. The device was reviewed via the Direct premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2018-10-05.

Classification & Regulation

This clearance is catalogued under FDA product code QDD and 21 CFR 874.3325, within the Ear, Nose, Throat review panel as a Class II device.