Food and Drug Administration (FDA) Clears the Way for Hearing Aid Manufacturers to Label Hearing Aids With Immunity Information
Brenda Battat associate executive director of SHHH and Carol Rogin executive director of the Hearing Industries Association (HIA) met July 26, 2005 with FDA officials to discuss hearing aid labeling for compatibility with mobile phones.
SHHH believes that hearing aid labeling based on the ANSI C63.19 standard is necessary to help consumers select a hearing aid and mobile phone that should work together without interference. The FCC requires that mobile phones be rated and labeled according to the same ANSI standard.
Hearing aid manufacturers have been unwilling to label their hearing aids with the immunity level to interference when used with mobile phones. They are concerned that if a hearing aid does not measure up to the label that the company could face regulatory action by the FDA. The FDA has assured HIA that if a hearing aid is labeled according to a standardized laboratory test in accordance with ANSI C63.19 that the FDA would not take enforcement action against a product that conveyed that information on the label. Nor would the FDA “have concerns about an assertion on the label of a hearing aid that individual hearing users will have varying results with cell phones.”1
SHHH’s position is that the hearing aid industry should label its products to inform consumers of the immunity level of the hearing aid they are purchasing. The labeling should provide adequate information to help consumers buy a mobile phone. The information should be consistent with the C63.19 standard. We are fully aware that testing in the laboratory in the prescribed way may not mirror 100% what happens in real-life usage and that hearing aids customized after purchase may perform differently. Therefore, consumers should try the hearing aid with the mobile phone in the store before purchasing and take advantage of the trial period and refund/exchange policy to test the phone and hearing aid together in real life situations
We understand that the FDA cannot approve labeling language but support and encourage the FDA’s offer to give assurance in writing to the hearing aid manufacturers that the labeling language does not violate health regulations.
SHHH also requests that the hearing aid manufacturers give testing data to hearing aid dispensers explaining in plain language the immunity levels of the products they sell so that they in turn can inform consumers of the immunity level of the hearing aid they are purchasing.
