FDA Greenlights Bone Conduction Implant System The U.S. Food and Drug Administration (FDA) has cleared a bone conduction hearing implant system for sale later this year. The BONEBRIDGE™ system from MED-EL USA, for people ages 12 and older who have conductive hearing loss, mixed hearing loss or single-sided deafness, entered the European market in 2012. It ... News in Brief
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News in Brief  |   October 01, 2018
FDA Greenlights Bone Conduction Implant System
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Hearing & Speech Perception / Regulatory, Legislative & Advocacy / News in Brief
News in Brief   |   October 01, 2018
FDA Greenlights Bone Conduction Implant System
The ASHA Leader, October 2018, Vol. 23, 12. doi:10.1044/leader.NIB1.23102018.12
The ASHA Leader, October 2018, Vol. 23, 12. doi:10.1044/leader.NIB1.23102018.12
The U.S. Food and Drug Administration (FDA) has cleared a bone conduction hearing implant system for sale later this year.
The BONEBRIDGE™ system from MED-EL USA, for people ages 12 and older who have conductive hearing loss, mixed hearing loss or single-sided deafness, entered the European market in 2012. It has two components: an internal implant and an audio processor.
Rather than a bone-anchored implant with an abutment that protrudes through the skin, BONEBRIDGE keeps the patient’s skin intact. The implant is placed completely underneath the skin and magnetic attraction keeps the audio processor attached.
The audio processor can automatically identify and minimize noise interference and direct the microphone to the source of speech. Users can select one of five programs for particular situations, such as a noisy environment or for television and music.
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October 2018
Volume 23, Issue 10