Agreement with Connecticut Regulators
March 15, 2022
Lively Hearing Corporation, a leading provider of direct-to-consumer hearing aids and professional support, is pleased to announce the Connecticut Office of the Attorney General and Department of Consumer Protection have concluded a review of Lively's sale of hearing aids in Connecticut without finding any violation of state law, rule or regulation.
Adam Karp, Lively's CEO, said "Lively takes seriously its obligation to comply with applicable federal and state regulation in providing our vital and innovative hearing services to our customers, and the conclusion of this review without any negative findings demonstrates that commitment. One of Lively's core values is that we care deeply for our customers. We applaud the efforts of the Connecticut AG and DCP Commissioner, with which we cooperated fully, and others in reviewing the practices of participants in our industry and protecting the consumer."
In connection with the closure of the review, Lively entered into a voluntary agreement with the CT Department of Consumer Protection in which Lively agreed to make a payment of $15,000 for investigative costs, and not to refer to its hearing aids as "FDA Approved" unless and until the US Food & Drug Administration has specifically approved them or has issued guidance permitting the use of such term in connection with the types of hearing aids Lively sells.
Like most hearing aids, Lively's hearing aids do not require specific FDA approval. Lively's hearing aids have the same technology and quality as many models typically sold through audiologist offices, and are sold in compliance with FDA and state regulation applicable to hearing aids. This includes being sold on an FDA-required "restricted device" basis with the oversight and involvement of Lively's trained and licensed audiologists and hearing aid dispensers, not "over-the-counter".