Last synced on 2 December 2022 at 11:04 pm

Electronic Media, Hyperacusis

Page Type
Product Code
Definition
To improve sound tolerances.
Physical State
compact disc
Technical Method
Compact disc containing broadband pink noise.
Target Area
brain
Review Panel
Ear, Nose, Throat
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OAQ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Electronic Media, Hyperacusis

Page Type
Product Code
Definition
To improve sound tolerances.
Physical State
compact disc
Technical Method
Compact disc containing broadband pink noise.
Target Area
brain
Review Panel
Ear, Nose, Throat
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code OAQ is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.