Last synced on 14 June 2024 at 11:05 pm

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Page Type
Product Code
Definition
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
Physical State
The device may include a headphone for sound stimulation, a electrical stimulator for transmucosal/transcutaneous electrical stimulation, and a controller (hardware and software) to generate and control the sound and electrical stimulation.
Technical Method
Uses a headphone to deliver sound stimulation and a transmucosal/transcutaneous electrical stimulator to deliver electrical stimulation.
Target Area
Ear, tongue, skin etc.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3410
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVN is linked to regulation 21CFR874.3410, which does not seem to exist yet. It may be pending at the moment.

Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus

Page Type
Product Code
Definition
A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus.
Physical State
The device may include a headphone for sound stimulation, a electrical stimulator for transmucosal/transcutaneous electrical stimulation, and a controller (hardware and software) to generate and control the sound and electrical stimulation.
Technical Method
Uses a headphone to deliver sound stimulation and a transmucosal/transcutaneous electrical stimulator to deliver electrical stimulation.
Target Area
Ear, tongue, skin etc.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.3410
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QVN is linked to regulation 21CFR874.3410, which does not seem to exist yet. It may be pending at the moment.