Search
Hearing Aids
… /medical-devices/consumer-products/hearing-aids … UPDATE - May 3, 2023: The FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid. Having trouble hearing? Close to 30 million …
Other Hearing Devices and Products
… /medical-devices/hearing-aids/other-hearing-devices-and-products … On this page: Assistive … Listening Devices Cochlear Implants Implantable Middle Ear Hearing Devices Bone-Anchored Hearing Aids Personal Sound …
OTC Hearing Aids: What You Should Know
… /medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know … Close to 30 million adults living in the U.S. have some degree of hearing loss . Despite the high number of people affected by …
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products
… ation/search-fda-guidance-documents/regulatory-requirements-hearing-aid-devices-and-personal-sound-amplification-products … Federal Food, Drug, and Cosmetic Act (the FD&C Act) for hearing aids and for personal sound amplification products (PSAPs). A lack of clarity between PSAPs and hearing aids has contributed to stakeholder and consumer …
Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS) - Guidance for Industry and FDA
… al-controls-guidance-document-transcutaneous-air-conduction-hearing-aid-system-tachas … Document Issued on: November 7, … Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA 1. … the classification of the Transcutaneous Air Conduction Hearing Aid System (TACHAS) into Class II (Special Controls). …
Nucleus 24 Cochlear Implant System – P970051/S205
… gives a person access to sound by directly stimulating the hearing nerve (auditory nerve). The cochlear implant system … 9 months and older with severe to profound sensorineural hearing loss in both ears. This approval expands the use for … people ages 5 years and older with severe to profound hearing loss in one ear (single-sided deafness/unilateral …
Voluntary Field Corrective Action of HiRes Ultra and Ultra 3D
… their device as normal. If recipients experience issues of hearing degradation they should visit their audiologist or … device explants related to low impedances and reports of hearing performance degradation. As of February 11, 2020, of … contribute to the clinical symptoms leading to explant and hearing performance degradation. This information will be …
Neuro Cochlear Implant System – P200021
… Implant System is intended to provide the user with hearing sensation through electrical stimulation of the hearing nerve (auditory nerve). The system consists of an … System is used in patients 18 years and older, with hearing impairment ( deafness ) that is not improved by …
Examples of Device Software Functions the FDA Regulates
… and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of … audiometer to allow healthcare professionals to determine hearing loss at different frequencies. Possible product code: … 870.1110), DXN (21 CFR 870.1130). Are used to calibrate hearing aids and assess the electroacoustic frequency and …
Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Physician Notification Orders
… FDA’s reconsideration decision, it may request a formal hearing before the Departmental Appeals Board, Department of … and Human Services, as well as further review of the hearing officer’s decision. A mammography facility that … Standards Act (MQSA) may request an informal (regulatory) hearing before the FDA as described below. The FDA has …
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 …
Mammography Facility Adverse Event and Action Report - June 30, 2022: Capitol Radiology, LLC doing business as Laurel Radiology Services
… Revoke Certificate, along with notice of opportunity for hearing, explaining the supporting facts and attaching the … Capitol Radiology ten business days to request an informal hearing regarding the proposed revocation. On January 27, … notice by email that it was requesting an informal hearing regarding CDRH's proposed revocation of Capitol …
Curewave Lasers LLC - 593692 - 12/12/2019
… the findings in this letter by requesting a regulatory hearing before the FDA. However, a hearing is not required to respond to this letter with a … be evaluated. Information about requesting a regulatory hearing before FDA can be found in 21 CFR Part 16. A request …
September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement - 09/10/2019
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
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 …
IDE Enforcement of Good Clinical Practices (GCP) Regulations
… investigator will be given an opportunity for a regulatory hearing under 21 CFR 16 on the question of whether the … the sponsor who will have an opportunity for a regulatory hearing. If a danger to the public health exists, however, … the sponsor will have an opportunity for a regulatory hearing before FDA on the question of whether the IDE should …
IDE Approval Process
… respond to the deficiencies and/or to request a regulatory hearing under 21 CFR Part 16. Once an IDE application is … request as a disapproval of the application and request a hearing in accordance with 21 CFR 16. The clinical … advise the sponsor of the right to request a regulatory hearing under 21 CFR 16. FDA will provide an opportunity for …
October 22, 2020: Patient Engagement Advisory Committee Meeting Announcement - 10/22/2020
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
October 6, 2021: Patient Engagement Advisory Committee Meeting Announcement - 10/06/2021
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
July 12-13, 2022: Patient Engagement Advisory Committee Meeting Announcement - 07/12/2022
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested … Individuals who do not wish to speak at the open public hearing session but would like their comments to be heard by …
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 …
General Controls for Medical Devices
… all interested persons an opportunity for an informal hearing on the proposal, the Agency will affirm, modify, or … the FDA, after offering an opportunity for an informal hearing, to order manufacturers, importers, or distributors … or refund (3-R) if, after opportunity for an informal hearing , it determines that: The device represents an …
CDRH Provides Update on Philips June 2021 Recall and Maintains Recommendations Related to Potential Health Risks of PE-PUR Foam
… from the company. Notice of Opportunity for an Informal Hearing Additionally, the FDA issued to Philips a notice of opportunity for an informal hearing on CDRH's proposal that a section 518(b) order should … after November 2015. Philips did not request a hearing but instead submitted a written response relating to, …
POSTPONED: June 9, 2020: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 06/09/2020 - 06/09/2020
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …
June 19-20, 2019: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement - 06/19/2019 - 06/20/2019
… reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested …