This action was brought against a leading manufacturer EIGHTEEN YEARS after the FDA regulated the industry in 1977.
The spokesman for the Justice Department – Assistant Attorney General Frank Hunger of the Civil Division commented: “We see this settlement as an expression of the Department’s determination to pursue individuals and businesses who would deceive consumers, especially the elderly, by claiming that their products can do things they cannot do. Hopefully, this action will serve as a deterrent to those who try to take advantage of others.”
DAHLBERG PAYS RECORD PENALTY OF $2.75 MILLION TO SETTLE SUIT
Tuesday, November 21, 1995
Justice Department Press Release
WASHINGTON, D.C. — The maker of the so-called “miracle ear clarifier” today agreed to pay a record
$2.75 million to settle allegations it violated an administrative order which prohibited it from making performance claims for its hearing aids that were not supported by reliable scientific or medical evidence, the Department of Justice announced.
Dahlberg Inc., a wholly owned subsidiary of Bausch & Lomb, agreed to pay the civil penalty to settle claims it violated the Federal Trade Commission Act by using unfair and deceptive practices in advertising its hearing aids between 1988 and 1993, the Department of Justice announced. This is the largest settlement of a consumer protection action alleging violations of an administrative order.
In a proposed consent decree filed in U.S. District Court in Minneapolis, Minnesota, Dahlberg also agreed not to engage in future practices that could violate the order, such as advertising that its hearing aids possessed performance characteristics that were not established by scientific fact.
Assistant Attorney General Frank Hunger of the Civil Division said, “This is an important step in protecting American consumers from advertising that contains misleading or false information that could lead to purchasing medical products that have no scientific basis to support their claims.
“We see this settlement as an expression of the Department’s determination to pursue individuals and businesses who would deceive consumers, especially the elderly, by claiming that their products can do things they cannot do. Hopefully, this action will serve as a deterrent to those who try to take advantage of others.”
In February 1994, the Department, on behalf of the Federal Trade Commission, filed a complaint seeking civil penalties and injunctive relief from Dahlberg for advertising that its hearing aids could block out background noise and amplify only speech when, in fact, they could not.
The complaint alleged that Dahlberg violated a 1976 administrative order issued by the FTC when it advertised on television and in the print media from 1988 through 1993 that its Miracle Ear Clarifier Hearing Aids could block out background noise and amplify only speech in a noisy listening environment.
In fact, the “clarifier” could not amplify only speech and block out background noise.
In addition, there was no evidence that the device was able to enhance the listening capability of a hearing impaired user in a noisy listening environment through a technology unique to the “clarifier” or that “clarifiers” were superior to other hearing aids with similar technology.
Under the decree, the company may advertise that its hearing aid products have performance characteristics approved by the Food and Drug Administration based on scientific evidence, but risks violating the administrative order by making other unapproved performance claims. The decree also prohibits the company from engaging in any additional violations of the administrative order.
The decree must be approved by the court.
Some 40,000 consumers, many of whom were elderly, purchased clarifiers between 1988 and 1993.