FDA Approval and Launch Scope

Samsung Electronics (005930.KS) has obtained FDA approval for the hearing aid feature in the Galaxy Buds3 Pro and Galaxy Buds4 Pro. The target group is adults aged 18 and over who self-identify as having mild to moderate hearing loss. These devices will be classified as over-the-counter (OTC) medical devices available without a prescription. This is not a Phase 1, 2, or 3 drug trial; it is an approval at the regulatory stage. Commercialization of the feature is scheduled for the fourth quarter of 2026 in the United States and other approved markets, so it is important to distinguish between approval and launch timing.

Self-Test and Personalized Audio Correction

The medical device software (SaMD), a hearing test, performs a pure-tone audiometry test for approximately 5 minutes to create an audiogram for each ear. The hearing aid feature amplifies high frequencies and quiet sounds based on these results, and enhances conversational audio through noise reduction and beamforming. The participation of the National Acoustic Laboratories (NAL), Samsung Seoul Hospital, and Vanderbilt University Medical Center in the development and clinical validation indicates a combination of the convenience of general earphones with a medical device performance management system.

Pressure on Apple and Traditional Hearing Aid Companies

The direct competitor is Apple's (AAPL) hearing aid feature for the AirPods Pro 2, which received De Novo approval as the first OTC hearing aid software (DEN230081) from the FDA on September 12, 2024. The FDA's OTC hearing aid regulation, which took effect on October 17, 2022, broadened access by allowing adults to set up the devices themselves without professional fitting. Samsung's entry will increase price and distribution pressure on self-adjusting products from companies such as Sonova (SOON.SW), GN Store Nord (GN.CO), and WS Audiology, as well as Apple. However, it is not a product that replaces devices for severe or profound hearing loss or patients who require professional care.

Market Potential and Ecosystem Strategy

Grand View Research forecasts the global OTC hearing aid market to grow from USD 1.11 billion in 2023 to USD 1.74 billion in 2030, with a compound annual growth rate of 6.6%. Samsung will deploy the feature on existing Buds hardware and Galaxy devices with One UI 8 or later without separate acquisitions or licensing agreements. Therefore, initial profitability will stem from device differentiation and ecosystem retention rather than direct treatment revenue, similar to new drugs. The actual launch scope, the number of supported devices, and the user activation rate in the fourth quarter of 2026 will be key indicators of whether the medical device approval will lead to increased Buds sales and Galaxy customer loyalty.