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…
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.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen WAP-Health Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 16 |
Record
| 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
| 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 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| HyperSound Clear 500P | Withdrawn |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.