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MAH — Hearing Aid, Bone Conduction, Implanted Class II

FDA Device Classification

Classification Details

Product Code
MAH
Device Class
Class II
Regulation Number
874.3302
Submission Type
Review Panel
EN
Medical Specialty
Ear, Nose, Throat
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K203807oticon medicalPonto Bone Anchored Hearing System, MONO Surgery KitMarch 3, 2021
K182116cochlear americasBA310 Abutment, BIA310 Implant/AbutmentDecember 19, 2018
K152820oticon medicalPonto Bone Anchored Hearing SystemJanuary 22, 2016
K152067oticon medicalPonto bone anchored hearing systemNovember 23, 2015
K150555cochlear americasBA400 14mm AbutmentJuly 15, 2015
K142678oticon medicalPonto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing January 21, 2015
K121317cochlear americasCOCHLEAR BAHA IMPLANT SYSTEMOctober 12, 2012
K121228oticon medicalPONTO BONE ANCHORED HEARING SYSTEMSeptember 7, 2012
K112053oticon medicalOBC BONE ANCHORED HEARING SYSTEMNovember 18, 2011
K080363cochlear bone anchored systemsBAHA CORDELLE IIApril 10, 2008
K984162nobelpharma usaBRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USEJune 28, 1999