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主动经皮骨传导植入物(Osia 系统)在高频和噪声环境下的表现,以及从 Baha attract 系统转换过来的使用者的听力:一项前瞻性研究。

Performance of an active transcutaneous bone conduction implant, the Osia system, in high frequencies and hearing in noise in users converted from a Baha attract system: a prospective study.

机构信息

AP-HP, Bicêtre Hospital, Department of Head and Neck Surgery, School of Medicine, Paris-Saclay University, 94070, Le Kremlin-Bicêtre, France.

Paris Saclay University, Bâtiment Bréguet, 3 Rue Joliot Curie, 91190, Gif-Sur-Yvette, France.

出版信息

Eur Arch Otorhinolaryngol. 2023 Oct;280(10):4691-4696. doi: 10.1007/s00405-023-08149-9. Epub 2023 Aug 14.

DOI:10.1007/s00405-023-08149-9
PMID:37578496
Abstract

PURPOSE

Hearing rehabilitation through middle ear surgery can be challenging, particularly for patients with chronic otitis media, but new hearing devices offer opportunity to reach this goal. The aim was to compare hearing outcomes and quality of life in patients who were converted from a Baha Attract system to the Osia system.

METHODS

Prospective observational study, in which each subject acted as their own control. Six patients who were converted from a Baha Attract to an Osia system performed audiometric and quality of life assessments with different sound processor at fitting, 3, 6 and 12 months. The speech performance in noise with the Osia system at 12 months, expressed as dB SNR, was compared to the baseline condition (Baha 5).

RESULTS

The PTA4 hearing thresholds improved from 42.6 ± 11 with Baha 5 Power to 34.8 ± 13.3 with Baha 5 SuperPower and to 25.4 ± 3.5 with the Osia at 12 months, leading to a significant functional gain of 17.2 ± 10.9 dB vs Baha 5 (p < 0.02). Speech understanding in both quiet and noise was clinically improved reaching a mean SNR of less than 1 dB at 12 months with the Osia system. Quality of life outcomes improved by more than 20% at 12-month follow-up.

CONCLUSION

Aided hearing thresholds and speech understanding in noise improved when patients were converted from the Baha Attract system to the Osia system. The aided hearing threshold was maintained up to 8 kHz (26 dB) with the Osia system.

摘要

目的

中耳手术的听力康复可能具有挑战性,特别是对于慢性中耳炎患者而言,但新型听力设备为此提供了机会。本研究旨在比较将 Baha Attract 系统转换为 Osia 系统的患者的听力结果和生活质量。

方法

前瞻性观察性研究,每位患者自身前后对照。6 例患者将 Baha Attract 系统转换为 Osia 系统,在佩戴、3 个月、6 个月和 12 个月时分别进行不同听力处理器的听力评估和生活质量评估。在 12 个月时,用 Osia 系统评估噪声下的言语表现,以 dB SNR 表示,与基线条件(Baha 5)进行比较。

结果

42.6±11dB 的 PTA4 听力阈值在使用 Baha 5 Power 时改善至 34.8±13.3dB,在使用 Baha 5 SuperPower 时改善至 25.4±3.5dB,在使用 Osia 时在 12 个月时改善至 17.2±10.9dB,与 Baha 5 相比具有显著的功能性增益(p<0.02)。在安静和噪声环境下的言语理解均得到临床改善,在使用 Osia 系统时 12 个月时的平均 SNR 小于 1dB。生活质量在 12 个月随访时提高了 20%以上。

结论

当患者将 Baha Attract 系统转换为 Osia 系统时,辅助听力阈值和噪声下的言语理解得到改善。Osia 系统可保持 8kHz(26dB)以下的辅助听力阈值。

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Success rates in restoring hearing loss in patients with chronic otitis media: A systematic review.慢性中耳炎患者听力损失恢复的成功率:一项系统评价。
Laryngoscope Investig Otolaryngol. 2021 May 12;6(3):522-530. doi: 10.1002/lio2.576. eCollection 2021 Jun.
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Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation.新型主动式骨结合种植系统Osia™的临床性能:一项前瞻性临床研究结果
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