IA #89-12, 5/12/95, "DWPE OF HEARING AID DEVICES LABELED AS PERSONAL
LISTENING/AMPLIFICATION PRODUCTS", Attachment A - 7/8/96, Attachment B -
1/12/07
NOTE: This revision is being issued to revise the alert into the current
format and terminology. Changes are bracketed by asterisks (***).
TYPE OF
ALERT: *** Detention Without Physical Examination (DWPE) ***
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.
PRODUCT: Hearing aid like devices
PRODUCT
CODE: 77E[][]SD - hearing aid, air conduction
77E[][]PF - hearing aid, group & auditory trainer
PROBLEM: CDRH has determined that the hearing aid like devices listed in
the attachment are hearing aid devices as defined in 21 CFR
874.3300(a) and/or group hearing aid devices as defined in 21 CFR
874.3320(a). These devices were offered for sale in interstate
commerce for the first time after May 28, 1976, thereby making
them Class III devices [Section 513(f)(1)]. These hearing aid
like devices are being marketed without an approved 510(k) or PMA
application.
PAF: REG (Registration & Listing)
PAC: 82008
COUNTRY: All countries (ZZ)
MANUFACTURER/
SHIPPER: See Attachment B
IMPORTER
ID: N/A
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)]."
AND
"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: No PMA
FALSE
RECOMMENDING
OFFICE: CDRH, OC , DOE II, (HFZ-331)
*** OASIS CHARGE
CODE: No PMA
False ***
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 on Attachment A from the firms identified on Attachment
B 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) 827-7605. ***
PRIORITIZATION
GUIDANCE: N/A
FOI: Purging is not necessary.
KEYWORDS: Hearing aids, amplification, listening, misbranded, PMA
PREPARED
BY: Ted Poplawski DIOP,(301) 443-6553
DATE LOADED
INTO FIARS:
ATTACHMENT A - HEARING AID LIKE DEVICES (LISTENING/AMPLIFICATION) 7/8/96
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
ATTACHMENT B - KNOWN MANUFACTURERS OF HEARING AID LIKE DEVICES -
LISTENING/AMPLIFICATION PRODUCTS 1/12/07
HONG KONG (HK)
FIRM NAME/ADDRESS: PRODUCT/PRODUCT CODE: DATE:
Azad International 5/12/95
Kowloon, Hong Kong
MID# HKKOWINTKOW
Sugar Three Company Hearing Aid, Sound EZ, 9/21/06
9 Kai Cheung Road 77N[][]IX
Kowloon Bay, Hong Kong
FEI# 3005529269
(Shipper)
Clearpoint International Hearing Aid, Sound EZ 1/12/07
Direct Marketing Inc. 77N[][]IX
7 Valois Bay Ave.
Pointe Claire, Canada
FEI# 3004899131
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