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FDA

FDA
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FDA

Product catalog summary
Overview: hearTest is a certified digital audiometry solution that integrates a tablet with a cloud data management platform for comprehensive audiometry. It is compliant with international standards and offers various benefits and features.
Registrations and Certifications: The device is FDA compliant in the United States, CE certified in Europe, and TGA certified in Australia. It adheres to ISO/ANSI/SANS standards.
Benefits & Features: The system provides automated testing, audiogram results with pure tone averages, and best practice protocols. It is cost-effective, offers extended high-frequency testing, and includes environmental noise warnings and conditioning features. It also supports digital data management and integration with video-otoscopy.
Technical Specifications: The device includes a Samsung Tab A, Sennheiser HD 280 Pro headphones, and a carry case. It offers different diagnostic hardware sets with varying frequency ranges and testing intensities. The system supports adjustable protocols and automatic masking features.
Protocols: The frequency range varies from 125 Hz to 16,000 Hz, with customizable protocols. Testing protocols include default and daily check protocols, with adjustable minimum testing intensity and response windows.
Tone Specifications: The device supports pure tone testing with optional masking across a wide range of frequencies and intensities.
Technical Specifications and Performance: The carry case is compact and lightweight, suitable for professional healthcare environments. The device is classified as a Class IIa medical device with specific safety and design standards.
Headphone Specifications: Detailed specifications for Sennheiser HD 280 Pro and RadioEar DD450 headphones are provided, including frequency and intensity ranges.
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Catalog excerpts

FDA-1

PURE TONE CLINICAL AUDIOMETER hearTest is a world-first certified digital audiometry solution that uses a tablet linked to a cloud data management platform for comprehensive audiometry.

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FDA-2

COMPLIES TO INTERNATIONAL STANDARDS . . . . IEC 60645-1 - Equipment for pure tone audiometry (type 4 audiometer) ANSI S3.6 - Specification for audiometers (type 4 audiometer) ISO 8253-1 - Pure tone air conduction audiometric test methods ISO 389 series - Reference zero for the calibration of audiometric equipment United States of America South Africa UNITED STATES (FDA COMPLIANT) BENEFITS & FEATURES CLINICALLY VALID TESTS AUDIOGRAM RESULT ENVIRONMENTAL NOISE WARNING Evidence-based, validated audiometer calibrated to ISO/ANSI/SANS standards. Audiogram with pure tone average and degree of loss classification....

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FDA-3

HARDWARE DIAGNOSTIC HARDWARE SET A Test down to 10 dB HL Samsung Tab A, Sennheiser HD 280 Pro headphones & carry case DIAGNOSTIC HARDWARE SET B Test down to -10 dB HL Samsung Tab A, Sennheiser HD 280 Pro headphones, v3 DAC & carry case DIAGNOSTIC HARDWARE SET C Test down to -10 dB HL Samsung Tab A, RadioEar DD450 headphones, v3 DAC & carry case PROTOCOLS Frequency range Testing protocol Custom protocol setup possible Default protocol (500, 1,000, 2,000, 4,000, 8,000 Hz) Daily check protocol (500, 1,000, 2,000, 4,000, 8,000 Hz) Threshold seeking methods Shortened Ascending (ISO 8253-1:2010) Intelligent...

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FDA-4

TECHNICAL SPECIFICATIONS AND PERFORMANCE Carry case dimensions • Includes a handle • Includes a shoulder strap Net weight (contents: tablet, headphones, and charger) Safety and design standards Medical device class Degree of protection (electric shock) Type B applied part Protection against ingress (IP): • Tablet • Headphones Usage environment Professional healthcare environment Operating temperature Humidity Ambient pressure 35 cm x 26 cm x 12 cm 13.77 inch x 10.23 inch x 4.72 inch TONE SPECIFICATIONS Type Pure tone with optional masking Rise / fall time 35 ms (-20 dBFS to -1 dBFS and vice versa)...

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FDA-5

*Referenced to 0 dB HL testing from 500 Hz and up *Referenced to 0 dB HL testing from 500 Hz and up

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All HearX Group catalogs and technical brochures

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  4. hear Screen
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*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.