*This is an archive page. The links are no longer being updated.
1993.04.26 :  Hearing Aid Claims
            
Contact: Sharon Snider (301) 443-3285 (Home) -- (301) 622-0977
April 26, 1993

      The Food and Drug Administration has told six major hearing
aid manufacturers and distributors to stop making misleading claims
about products.
      The warnings were issued to Dahlberg 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, Ill. 
      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 noisy environments such as
restaurants, baseball games, 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
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 hearing aids.
      FDA is one of the eight Public Health Service agencies within
HHS.
                              ####