TY - JOUR
T1 - Clinical performance of the Osia™ system, a new active osseointegrated implant system. Results from a prospective clinical investigation
AU - Goycoolea, Marcos
AU - Ribalta, Gloria
AU - Tocornal, Francisco
AU - Levy, Raquel
AU - Alarcón, Pilar
AU - Bryman, Martin
AU - Cagnacci, Byanka
AU - Catenacci, Catherine
AU - Oyanguren, Valeria
AU - Vilches, Ignacia
AU - Briones, Verónica
AU - García, Raimundo
N1 - Publisher Copyright:
© 2020, © 2020 Acta Oto-Laryngologica AB (Ltd).
PY - 2020/3/3
Y1 - 2020/3/3
N2 - Background: Bone-conduction hearing implants are standard of care devices. Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system. Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband. Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device. Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.
AB - Background: Bone-conduction hearing implants are standard of care devices. Aims/Objectives: Evaluation of a new active magnetic bone-conduction hearing implant: Cochlear Osia™ system. Material and methods: This device uses a transcutaneous connection between an external sound-processor and an osseointegrated implant that generates vibrations using a piezoelectricity-based internal bone-conduction system. Nine patients with conductive-hearing loss were implanted. Surgical efficacy, hearing performance and quality-of-life were evaluated. Hearing performance in quiet and in noise was compared with unaided hearing and hearing with the Baha 5 Power® Sound Processor on a softband. Results: Surgery and healing were uneventful. Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the Osia™ compared to preoperative unaided hearing and aided hearing with the Baha 5 Power® Sound Processor on a softband. The active vibration system provided improvement at low and high frequencies. At 6 months postoperatively, all patients continue to use the device. Conclusions and significance: The Osia™ is safe and effective, improving speech-recognition in quiet and in noise, at low and high frequencies, thus delivering better quality-of-hearing than passive devices.
KW - Active bone-conduction hearing-implant
KW - Baha
KW - Bone anchored hearing aid
KW - hearing improvement in high frequencies
KW - quality-of-hearing
UR - http://www.scopus.com/inward/record.url?scp=85079709962&partnerID=8YFLogxK
U2 - 10.1080/00016489.2019.1691744
DO - 10.1080/00016489.2019.1691744
M3 - Article
C2 - 32068449
AN - SCOPUS:85079709962
SN - 0001-6489
VL - 140
SP - 212
EP - 219
JO - Acta Oto-Laryngologica
JF - Acta Oto-Laryngologica
IS - 3
ER -