Product code OAF

Device name

Implant, Hearing, Active, Middle Ear, Totally Implanted

Medical specialty

Unknown

Device class

3

Review panel

EN

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.

Source

FDA openFDA device classification dataset