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510(k) Data Aggregation
(59 days)
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Mild to severe conductive, mixed or sensoryneural hearing loss
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
To amplify and transmit sound to the ear.
DSD K-amp or Intrigue programmable circuitry
Assembled from standard components that are widely used by other hearing aid manufacturers.
"Technical specifications comply with S3.2-1987 ANSI Standards"
Frequency response dictated by individual audiogram
Volume control similar to other devices.
Standard size 13 battery
Standard size 312 battery
Standard size 10A battery
Standard size 10a or 5a battery
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Auris hearing aids. The documents describe different models of Auris hearing aids, their intended use, features, technical characteristics, and the FDA's 510(k) clearance approval, but they do not include any specific clinical study data or performance metrics against defined acceptance criteria.
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