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CT AG $40K Settlement with Hearing Aid Companies Over False FDA Approval

Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., Wonder Ear, Inc.March 14, 2022Connecticut Attorney General

Penalty Amount

$40,000

Summary

Connecticut Attorney General William Tong announced settlements with four hearing aid companies for marketing their products as 'FDA-approved' when no such approval exists. The companies will collectively pay $40,000 and cease such marketing practices. The investigation underscores that over-the-counter hearing aids are not FDA-approved and consumers should be wary of such claims.

Remedy

The companies must stop marketing their hearing aids as FDA-approved and pay monetary penalties totaling $40,000 to the state of Connecticut.

Monetary PenaltyInjunction

Contract Impact

In-house legal teams should review vendor, customer, and marketing agreements for clauses addressing product representations, regulatory compliance, and advertising accuracy. Specifically, examine any warranties or statements regarding FDA approval or registration, marketing materials clauses, and compliance with consumer protection laws. Updates may be needed to remove 'FDA-approved' language, add clear disclaimers about regulatory status (e.g., 'FDA-registered but not approved'), and include covenants prohibiting false or misleading claims about government endorsement or product approvals.

Contract Search Terms

FDA approval representationmarketing claims clauseproduct regulatory statuscompliance with FDA regulationsmisleading advertising prohibitionwarranty of regulatory complianceproduct registration vs. approvaldisclosure requirementsconsumer protection complianceadvertising accuracy covenant

Violation Types

Entity Details

Entity

Lively Hearing Corporation, Widex USA, Inc., Hark Wellness, Inc., Wonder Ear, Inc.

Also known as: Lively Hearing, Widex USA, Hark Wellness, Wonder Ear

Industry

Healthcare

Official Sources

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