HyperSound

Primary DI
00869138000203
Brand
HyperSound
Company
TURTLE BEACH CORPORATION
Model
HyperSound Clear 500P
Catalog number
HPS-0500-04
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.
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPFHearing Aid, Group And Auditory Trainer
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPFHearing Aid, Group And Auditory TrainerEar, Nose, Throat2
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869138000203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869138000203008691380002038691380002030869138000203

GMDN Terms#

Term, Definition table
TermDefinition
Directed listening deviceA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-496-8001info@hypersoundhearing.com

Regulatory Flags#

DUNS number
059286532
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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05714880219906Audio ServiceWs Audiology Usa, Inc.KLW2026-05-28
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07613275596821PhonakSonova AGKLW2018-02-28
07613275596838PhonakSonova AGKLW2018-02-28