アップル「ＡｉｒＰｏｄｓ Ｐｒｏ ２」 補聴器機能をＦＤＡ承認

【サンフランシスコＡＦＰ＝時事】米電子機器大手アップルは１２日、イヤホン「ＡｉｒＰｏｄｓ Ｐｒｏ ２」に追加を予定している補聴器機能について、食品医薬品局（ＦＤＡ）の承認を受けたと明らかにした。補聴器市場に激変をもたらす可能性がある。（写真は資料写真）
　アップルは今週、ＡｉｒＰｏｄｓ Ｐｒｏ ２のアップデート版を発表。アップデート版には、聴力を検査し、日常生活やオンラインストリーミングで利用できる補聴器機能が搭載されるとしていた。
　ＦＤＡは１２日、同機器の補聴器機能を承認。専門家が調整した補聴器と同程度有益だとユーザーが評価したとする研究結果を報告した。
　ＦＤＡのミシェル・ターバー局長代行は「難聴は、大勢の米国人に影響が出ている深刻な公衆衛生問題だ」と指摘。アップルのソフトウエアは「軽度から中程度の難聴を自覚する成人に対して聴覚支援の利用しやすさ、入手しやすさ、受け入れやすさを向上させる」と説明した。
　ＡｉｒＰｏｄｓ Ｐｒｏ ２の価格は２４９ドル（約３万５０００円）と臨床グレードの補聴器としては格安だが、利用にはアップル社製携帯端末などが必要。
　アップルが示した研究結果によれば、軽度から中程度の難聴の人は、世界で１０億人以上いる。
　ＡｉｒＰｏｄｓ Ｐｒｏ ２の補聴器機能は１００以上の国と地域で、関連当局の承認が下り次第、今後数か月以内に利用可能になる見込み。【翻訳編集ＡＦＰＢＢＮｅｗｓ】
〔ＡＦＰ＝時事〕（2024/09/13-19:00）

Apple on Thursday got a green light from US regulators to add a feature that would let upcoming AirPods Pro ear pieces be used as hearing aids, potentially disrupting that market.
Earlier this week the company added AirPods Pro 2 to its lineup, touting a pending software upgrade that will let people test their hearing and then get assisted listening for everyday life as well as streaming online.
The US Food and Drug Administration (FDA) on Thursday authorized the hearing aid feature for the devices, noting that a study showed users found them as beneficial as professionally fitted ones.
Hearing loss is a significant public health issue impacting millions of Americans, said FDA acting director Michelle Tarver.
Apple's software advances the availability, accessibility and acceptability of hearing support for adults with perceived mild to moderate hearing loss, Tarver added.
AirPods Pro 2 are priced at $249, considerably lower than the average price of clinical-grade hearing aids, but those interested will need to adopt Apple's devices.
Along with the new feature, the AirPods Pro 2, used with iPhones or iPads, will be able to test hearing and create a user's hearing profile stored privately in an Apple Health app.
The test takes about five minutes, with users tapping an iPhone or iPad screen when they hear tones at various volumes and frequencies.
The results are then used to calibrate the hearing aid.
That profile is also automatically applied to music, movies, games, and phone calls across their devices without needing to adjust any settings, Apple said.
Typical hearing aids don't adapt specifically for streamed content or phone calls.
Hearing health is an essential part of our overall wellbeing, yet it can often be overlooked, Apple vice president of health doctor Sumbul Desai said in a release.
Apple said that research indicates more than a billion people worldwide live with mild to moderate hearing loss.
We are very excited about the new announcement by Apple, Hearing Loss Association of America executive director Barbara Kelley told AFP.
The fact that a product that millions of people already own will offer hearing help and protection is a big step forward.
The iPhone maker plans to make the features available in more than 100 countries in the coming months, pending authorization from relevent health authorities.
- Hearts and minds -
Apple has steadily been integrating health and fitness features into its products.
Apple Watch can remind people when to take medicine; warn of harmful noise levels, or detect an irregular heart rhythm that should be checked.
It can also let women know when they are likely ovulating.
A new version of Apple Watch announced this week adds the ability to detect sleep apnea, a dangerous condition in which breathing stops intermittently while sleeping.
An Apple Health App collects data then uses machine learning to mine it for insights, keeping information on devices, according to the tech titan.
Health metrics offered by Apple include heart and respiration rates; blood glucose, and how well one sleeps.