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U.S. Department of Health and Human Services

Import Alert 89-12
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 89-12
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Hearing Aid Devices Labeled As Personal Listening/Amplification Products"

Reason for Alert:
Hearing aid like devices (listening/amplification) are being advertised in such a way that CDRH has determined that they are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act. Hearing aid like devices are being commercially marketed without 510(k) clearance or an approved application for PMA. The labeling for the product may be false or misleading in that the user is led to believe that the use of this product will enhance their ability to hear. Also, these products may result in a delay by the user to seek traditional treatment for impaired hearing.

Guidance:
Districts may detain, without physical examination, the devices designated in the Product Description of this alert and firms identified in the attachment for this alert.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at 301 796-6600.

Product Description:
Hearing aid like devices:

Whisper XL
Super Ear
PowerHear mini-2000
Ampli-Fone
Whispersonic Super Ear
Audio Fone 6000
Power Hear
Whisper 2000
Listener 2000
Miracle Listening Amplifier
Wonder Ear
Super Sound 2000
Sonic 2000
MaxiSound Duo

Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to section 515 of the Act, or an exemption pursuant to section 520(g) [Adulteration, section 501(f)(1)(B)]."

OASIS charge code - NO PMA

"The device appears to be false or misleading in that the users are led to believe that the use of the article will enhance their ability to hear. [Misbranded, section 502(a)]."

OASIS charge code - FALSE
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