HyperSound

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…

Registry build 21.09.26

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.

1manufacturer
1catalogue number

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code EPF
Manufacturer City Province Registered as Device types
Shenzhen WAP-Health Technology Co., Ltd. Shenzhen Guangdong Repacker / relabeller 16

Record

Regulatory record for HyperSound
Listed by Turtle Beach Corporation, United States
FDA product code EPF
Device type Hearing Aid, Group And Auditory Trainer
Device class Class 2
Regulation 21 CFR 874.3320
Record published 2016-09-20
Record revised 2020-09-16 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Over the counter Yes
Label carries manufacturing date, serial number
Storage Storage environment temperature -20 to 50 °C
Distribution end date 2017-03-29

Catalogue Numbers

Catalogue numbers for HyperSound
Catalogue number Size Status
HyperSound Clear 500P Withdrawn

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

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2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer