HyperSound - Directed audio solution employing a fundamentally - TURTLE BEACH CORPORATION

Duns Number:059286532

Device Description: Directed audio solution employing a fundamentally new way to deliver sound. Device is inte Directed audio solution employing a fundamentally new way to deliver sound. Device is intended to improve sound clarity and speech intelligibility for individuals with hearing loss. The device is programmable and customizable by a hearing professional to a listener's hearing profile and preferences and other operating parameters are adjustable by the user.The device consists of an amplifier and specialized speakers connectable to an audio source (e.g., television, CD player); the speakers emit an ultrasonic beam with sound waves reproduced within the beam directed at the user. It is intended to be used with or without a hearing aid(s).An internal tinnitus software module may be activated and fitted by a hearing care professional for patient home use in the temporary relief of tinnitus symptoms. Upon module activation the device generates and delivers personalized sound output to tinnitus patients with or without hearing loss and with or without hearing aids.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

HPS-0500-04

Brand Name

HyperSound

Version/Model Number

HyperSound Clear 500P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 29, 2017

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

EPF

Product Code Name

Hearing Aid, Group And Auditory Trainer

Device Record Status

Public Device Record Key

88d82b6b-531f-415c-8b44-dddf486f8dcf

Public Version Date

September 16, 2020

Public Version Number

3

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TURTLE BEACH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1