AccessGUDID - DEVICE: HyperSound (00869138000203)

GUDID

Device Identifier (DI) Information

Brand Name: HyperSound
Version or Model: HyperSound Clear 500P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HPS-0500-04
Company Name: TURTLE BEACH CORPORATION

Primary DI Number: 00869138000203
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 059286532 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61909	Directed listening device	A mains electricity (AC-powered) audio device intended to improve the listening experience of a person who has difficulty hearing or who is hearing impaired by creating ultrasound-directed sound waves targeted at the individual without the need for earphones or headphones. It consists of an amplifier and specialized emitters (speakers) which are connected 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 and operating parameters may be configured for the individual.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EPF	Hearing Aid, Group And Auditory Trainer
KLW	Masker, Tinnitus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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