Phonak Audéo Paradise P90 Behind-the-Ear Hearing Aid
The Phonak Audéo Paradise P90 is a premium behind-the-ear (BTE) hearing aid designed for individuals with moderate to profound hearing loss. It features advanced speech enhancement technology and Bluetooth connectivity for direct streaming from iOS and Android devices. Classified under HTS 9021.40.00.00 as a complete hearing aid excluding parts, it compensates for hearing defects through amplification and sound processing.
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Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If marketed as general wireless earbuds without medical claims
Devices primarily functioning as headphones for entertainment fall under Chapter 85 telecommunications equipment rather than medical appliances.
If for replacement parts like batteries or ear domes sold separately
HTS 9021.40 specifically excludes parts and accessories, which are classified in 9033 as parts for instruments of Chapter 90.
If includes integrated diagnostic or testing functions beyond amplification
Devices with medical monitoring capabilities may shift to heading 9018 for medical instruments other than those for disabilities.
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Import Tips & Compliance
• Obtain FDA 510(k) clearance documentation and include it with commercial invoices to prove medical device compliance
• Label products clearly with model number, serial number, and 'Hearing Aid' to meet U.S. labeling requirements under 21 CFR 801
• Avoid classifying as consumer electronics; provide clinical performance data to justify medical appliance status and prevent reclassification
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