Department of Head and Neck Surgery, Hainan Cancer Hospital, Haikou, Hainan, China.
Medical Affair Department, Cochlear Great China, Beijing, China.
PLoS One. 2024 Sep 3;19(9):e0307044. doi: 10.1371/journal.pone.0307044. eCollection 2024.
Real-world evidence is increasingly used to support clinical and regulatory decisions globally and may be a useful tool to study the unique needs of cochlear implant users in China. The ability to recognize and understand speech in noise is critical for cochlear implant users, however, this remains a challenge in everyday settings with fluctuating competing noise levels. The Cochlear™ Sound Processor, Nucleus® 7 (CP1000), includes Forward Focus, a spatial noise algorithm aimed to improve speech-in-noise performance, and Made for iPhone/iPod/iPad functionality. We conducted a prospective, single-center, open-label, within-participant, real-world evidence investigation in participants with cochlear implants. The primary objective of this study, conducted in China, was to compare speech perception in spatially separated dynamic noise with the Nucleus 7 to the recipients' current older Cochlear Sound Processor, including the Freedom and Nucleus 5 sound processors. A follow-up study monitored participants from the initial study up to 12-months post the fitting of their Nucleus 7 and investigated hearing ability, satisfaction, and usability of the device via a questionnaire. Forty participants were included in the initial study (age-range 3 to 49 years) and 29 continued to the follow-up study (age-range 5 to 28 years). The participants were heterogeneous in terms of age, cochlear implant experience, and duration of hearing loss. Nucleus 7 significantly improved participant speech recognition performance in noise by 7.54 dB when compared with the participants' current older sound processor (p<0.0001). Overall satisfaction with Nucleus 7 was 72%. Satisfaction in different hearing contexts ranged from 93.1% for understanding a 1:1 conversation in a quiet setting, 62.1% for understanding on the phone, to 34.5% hearing in complex noisy situations. The study demonstrated the benefits of the Nucleus 7 sound processor across different hearing environments in a Chinese population and showed improved hearing ability, usability, and satisfaction in a real-world every-day environment.
真实世界证据在全球范围内越来越多地用于支持临床和监管决策，并且可能是研究中国人工耳蜗使用者独特需求的有用工具。在嘈杂的环境中识别和理解言语对于人工耳蜗使用者来说至关重要，但在竞争噪声水平波动的日常环境中，这仍然是一个挑战。 Cochlear™ 声音处理器，Nucleus® 7（CP1000），包括前向聚焦，这是一种旨在提高噪声环境中言语表现的空间噪声算法，以及 Made for iPhone/iPod/iPad 功能。我们在中国进行了一项前瞻性、单中心、开放标签、参与者内、真实世界证据研究。该研究的主要目的是比较空间分离动态噪声下的言语感知与 Nucleus 7 与接受者当前较旧的 Cochlear 声音处理器的性能，包括 Freedom 和 Nucleus 5 声音处理器。后续研究监测了初始研究中的参与者，直到他们佩戴 Nucleus 7 后的 12 个月，并通过问卷调查调查了参与者的听力能力、满意度和设备可用性。初始研究纳入了 40 名参与者（年龄范围为 3 至 49 岁），其中 29 名参与者继续进行后续研究（年龄范围为 5 至 28 岁）。参与者在年龄、人工耳蜗植入经验和听力损失持续时间方面存在差异。与参与者当前较旧的声音处理器相比，Nucleus 7 可使参与者的噪声言语识别性能提高 7.54dB（p<0.0001）。对 Nucleus 7 的总体满意度为 72%。不同听力环境下的满意度范围从安静环境中理解 1:1 对话的 93.1%，理解电话的 62.1%，到复杂嘈杂环境中的 34.5%。该研究表明，在中国人群中，Nucleus 7 声音处理器在不同听力环境中具有优势，并在真实的日常环境中显示出听力能力、可用性和满意度的提高。
