Docket Management
Docket: 02D-0228 - Medical Devices; Implantable Middle Ear Hearing Device; Draft Guidance for Industry & FDA
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Dr. John Zeigler Date/Time 2002-09-10 23:32:06
Organization Lake County Hearing Clinic
Category Health Professional

Comments for FDA General
Questions
1. General Comments Approximately 10 years ago the FDA sent notices to several hearing instrument manufacturers that their advertising content was misleading and often placed unsubstantiated claims in advertising content. This material was often passed on to individual dispensers who then used the material in newspaper and direct mail advertising. Currently much advertising has reverted to this type of content. Unsubstantiated claims are not protected by the first admendment. For example, non-audiology dispensers use the term audioprothologists which when read by a consumer is easily confused with the term Audiologist. The first admemdment does not protect the use of terms created to phonetically sound like and visually look like a protected term. The public has a right to know the credentials of the individual who is conducting any and all hearing tests. (See below) If the FDA wants to help consumers understand the process of remediation for hearing loss the first thing it should do is restrict all pre-amplification evaluation protocols and tests to the direct supervision of a licensed physician or Audiologist. Advertising Hearing Tests for the purpose of selecting amplification requires the assessment of the auditory system and the current FDA approved disclaimers noting that the examination is not a medical examination is not enough information for the public to understand it's limitations. In fact, the statement can be read by the public to be an inadvertent stamp of approval by the FDA indicating to the consumer that such an evaluation is appropriate in isolation from a medical consultation with a physician which may include an Audiological report. The FDA required statement that these hearing tests are not a medical examination... or that they are done for purpose of selecting amplification only misleads the public into believeing that such a thing should be allowed and implies that the FDA accepts this standard as being in the publics best health interests. The FDA does not allow an eye examination to be conducted for the purpose of selecting eyeglasses only... why should it allow hearing aids to be sold with such a ludricious disclaimer? Hearing aids can mask hidden serious medical disorders that must be determined before amplification should even be discussed.




EC -2