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CDRH Petitions
… FDA-2003-P-0275 Etymotic Research, Inc. Over-the-counter Hearing Aids 08/12/2003 02/13/2004 FDA-2003-P-0278 … GudHear, Inc. Professional and Patient Labeling for Hearing Aid Devices 08/12/2003 02/13/2004 FDA-2003-P-0403 … FDA-2008-P-0159 Missouri State Board of Examiners for Hearing Instrument Specialists Application for Exemption from …
CDRH 2022 Annual Report
… (MDUFA) V, Device Innovation, Over-the-Counter (OTC) Hearing Aid Final Rule, and Device Safety. Read the Report … Authorizations for Novel Devices Digital Health OTC Hearing Aid Final Rule Device Safety Recalls Cybersecurity …
List of Patient Preference-Sensitive Priority Areas
… Ear, Nose, and Throat Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment options) Ear, Nose, and … Tradeoffs Related to: Treatments for moderate to severe hearing loss (implanted hearing devices vs. other treatment …
Evaluation of Automatic Class III Designation (De Novo) Summaries
… DEN180041 Classification Order Decision Summary Bose Hearing Aid DEN180026 Classification Order Decision Summary … Classification Order Decision Summary EarLens™ Contact Hearing Device DEN150002 Classification Order Decision … Order Decision Summary Widex C4-PA Wireless Air-Conduction Hearing Aid DEN100025 Classification Order Decision Summary …
CDRH 2021 Annual Report
… in Action Digital Transformation Digital Health OTC Hearing Aid Rule Regulatory Science Tools Customer Service … …
510(k) Third Party Performance Metrics and Accreditation Status
… after providing notice and an opportunity for an informal hearing, when the accredited third party is substantially not …
CDRH Patient Engagement
… from the medical devices that it regulates. Benefits of hearing from patients could be experienced at all stages of …
Explore Life at CDRH
… safe, and effective medical devices. As a hard-of-hearing engineer, I also volunteer time on disability …