The integration of medical grade amplification into consumer audio hardware reached a regulatory turning point with the clearance of Apple’s Hearing Aid Feature (HAF). On September 12th, 2024, the United States Food and Drug Administration (FDA) granted marketing authorisation for HAF as the first over the counter (OTC) hearing aid software device. The regulatory determination was executed under the FDA’s De Novo premarket review pathway, establishing a classification for sof

There was no keynote, no press release, no carefully art-directed product shot. Apple's latest acquisition surfaced the way most of its acquisitions do: through a regulatory filing nobody was supposed to notice. Buried in the European Union's database of mergers likely to be significant in the region, a single entry revealed that Apple had acquired Sonera, a Berkeley born startup that builds non-invasive sensors capable of reading neural signals straight from the brain and bo