Printer Friendly

FDA WARNS HEARING AID FIRMS TO STOP MISLEADING CLAIMS

 WASHINGTON, April 26 /PRNewswire/ -- The Food and Drug Administration has told six major hearing aid manufacturers and distributors to stop making misleading claims about product performance or face regulatory action.
 The warnings were issued to Dahlbert Inc., Golden Valley, Minn.; Electone Inc., Longwood, Fla.; Siemens Hearing Instruments, Piscataway, N.J.; Omni Hearing Systems, Carrollton, Texas; Starkey Laboratories Inc., Eden Prairie, Minn.; and Beltone Electronics Corp., Chicago.
 FDA warned the firms in letters sent on April 16 that their advertising, promotion and labeling mislead the public by creating unrealistic expectations for the performance of their products. The firms represent some of the largest hearing aid manufacturers and distributors in the United States.
 "FDA will not tolerate misleading claims on hearing aid products," said FDA Commissioner David A. Kessler, M.D. "These companies have overstepped the line with their advertising. They must comply with the law, or the agency will take further action, including seizure of the product from the marketplace."
 FDA told the companies to remove all misleading promotional literature and advertising immediately and warned that continued distribution of the hearing aids with misleading claims could result in enforcement actions such as seizure, injunction and civil penalties. The agency also advised the firms to correct the misconceptions they have created by their misleading promotion and advertising.
 Under FDA regulations, companies may make claims about hearing aids as long as those claims can be supported by clinical data. FDA said that the companies getting letters have been claiming that their hearing aids significantly improve speech recognition and intelligibility in noisy environments such as restaurants, baseball gams, crowded rooms, theaters and church. The agency said the claims imply that users will be able to distinguish speech sounds from extraneous noises and that the hearing aids will not amplify background noises. These claims are misleading and are not supported by clinical data.
 According to the agency:
 -- The promotional materials fail to disclose important information about the limits of the devices' effectiveness and imply that most or all people who use these hearing aids will benefit equally -- a generalization that is not supported by scientific data. For example, although the hearing aids may improve the volume of sound for the user, they may not improve the intelligibility. The agency said these firms fail to disclose that some background noises will be amplified and that some speech sounds will not be.
 -- The promotional materials overstate the quality and value of the hearing aids with such claims as, "If you have nerve deafness, hearing again is no big thing."
 -- The promotional materials also mislead the public by including testimonials that are not supported by documentation or scientific evidence.
 Among the products in question are: Starkey Laboratories' Secret Ear; Beltone Electronics' ClearVoice, Prima LFE and Opera; Electone's


Gold Series, Faro I and II, Neptune and M30; Dahlberg's Miracle-Ear Clarifier and Micro Elite; Siemens' LifeSound models; and Omni Hearing Systems' Enviro 2000.
 The firms were given 15 days to inform the agency of corrective action they will take to bring their products into compliance with the law.
 An estimated 5.8 million people in the United States use hearing aids.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 4/26/94
 /NOTE: TV broadcasters: please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the Food and Drug Administration, 301-443-3285 or, after hours, 301-622-0977/


CO: Food and Drug Administration ST: District of Columbia IN: HEA SU:

IH-MH -- DC014 -- 0679 04/26/93 12:29 EDT
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Apr 26, 1993
Words:583
Previous Article:BP CHEMICALS INC. ACHIEVES ISO 9002 REGISTRATION
Next Article:FANNIE MAE ANNOUNCES POSTED YIELDS
Topics:


Related Articles
HEARING AID INDUSTRY PETITIONS FDA TO PERMIT AD CLAIMS ON 'QUALITY OF LIFE'
AHF Welcomes Federal 'False Advertising' Rebuke Against Drugmaker Abbott Over AIDS Drug Price Hike; FDA Calls Drugmakers' Ads 'Misleading,' Issues...

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters