綜合聽力和視覺解決方案的突破。EssilorLuxottica's Nuance Audio Glasses have received FDA clearance for over-the-counter sales in the U.S.

 

EssilorLuxottica 的 Nuance Audio 眼鏡已獲得 FDA 批准在美國非處方銷售，標誌著綜合聽力和視覺解決方案的突破。該公司根據歐盟醫療器材法規獲得 CE 標誌，計劃於 2025 年在歐洲推出，首先在義大利、法國、德國和英國推出。 這款智慧眼鏡將眼鏡與聽力技術結合在一起，在時尚的鏡框中提供開放式耳朵音訊解決方案。作為首個獲得 FDA 批准的軟體即醫療設備 (SaMD)，他們的目標是克服社會恥辱、舒適度和美觀度等阻礙助聽器普及的障礙。 全球有 12.5 億人患有輕度至中度聽力損失，EssilorLuxottica 計劃利用其廣泛的零售網路和聽力學實踐進行分銷。這款眼鏡標誌著向綜合健康解決方案的轉變，行業利益相關者正密切關注其對消費者採用的影響。

EssilorLuxottica's Nuance Audio Glasses have received FDA clearance for over-the-counter sales in the U.S., marking a breakthrough in integrated hearing and vision solutions. With CE marking under the EU’s Medical Devices Regulation, the company plans a European rollout in 2025, starting with Italy, France, Germany, and the UK.

The smart glasses combine eyewear with hearing technology, offering an open-ear audio solution in a stylish frame. As the first software-as-a-medical-device (SaMD) to receive FDA approval, they aim to overcome barriers like social stigma, comfort, and aesthetics that have deterred hearing aid adoption.

With 1.25 billion people worldwide experiencing mild to moderate hearing loss, EssilorLuxottica plans to leverage its extensive retail network and audiology practices for distribution. The glasses signal a shift toward integrated health solutions, with industry stakeholders closely watching their impact on consumer adoption.

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