HyperSound HPS-0500-04

GUDID 00869138000203

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.

TURTLE BEACH CORPORATION

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• Primary Device ID: 00869138000203
• NIH Device Record Key: 88d82b6b-531f-415c-8b44-dddf486f8dcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyperSound
• Version Model Number: HyperSound Clear 500P
• Catalog Number: HPS-0500-04
• Company DUNS: 059286532
• Company Name: TURTLE BEACH CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com
• Phone: 888-496-8001
• Email: info@hypersoundhearing.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869138000203 [Primary]

FDA Product Code

• EPF: Hearing Aid, Group And Auditory Trainer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-20