CDRH UNTITLED LETTERS: 7637W.Phoenix Management, Fountain, CO, June 5, 1998 (CDRH-OC). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. presented comments on its agreements with Phoenix regarding the HATIS HATIS Hearing Aid Telephone Interconnection System device. According to the letter, the company committed to revising its advertising by clarifying that HATIS works only "when connected to a hearing aid with a telecoil"; removing references to its use with cochlear implants Cochlear Implants Definition A cochlear implant is a surgical treatment for hearing loss that works like an artificial human cochlea in the inner ear, helping to send sound from the ear to the brain. , which would require a PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ; and remove claims for background noise. The agency noted that hearing aids and accessories became exempt from 510(k) requirements Feb. 19, 1998. However, manufacturers who made such claims should have supporting data available for evaluation by FDA, the letter stated. PMA |
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