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Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.
Cowan, Robert; Lewis, Aaran T; Hallberg, Carina; Tong, Michael C F; Birman, Catherine S; Ng, Iris H-Y; Briggs, Robert.
Afiliación
  • Cowan R; Department of Otolaryngology, The University of Melbourne, Melbourne, Australia.
  • Lewis AT; Cochlear Limited, Sydney, Australia.
  • Hallberg C; Cochlear Limited, Sydney, Australia.
  • Tong MCF; Department of Otorhinolaryngology, Head and Neck Surgery and Institute of Human Communicative Research, The Chinese University of Hong Kong, Hong Kong SAR, People's Republic of China.
  • Birman CS; Nextsense, Sydney, Australia.
  • Ng IH; Faculty of Medicine and Health, Sydney University, Sydney, Australia.
  • Briggs R; Faculty of Medicine and Health Sciences, Macquarie University, Sydney, Australia.
Eur Arch Otorhinolaryngol ; 281(2): 683-691, 2024 Feb.
Article en En | MEDLINE | ID: mdl-37552281
PURPOSE: To investigate 2-year post-operative hearing performance, safety, and patient-reported outcomes of hearing-impaired adults treated with the Osia® 2 System, an active osseointegrated bone-conduction hearing implant that uses piezoelectric technology. METHODS: A prospective, multicenter, open-label, single-arm, within-subject clinical study conducted at three tertiary referral clinical centers located in Melbourne, Sydney and Hong Kong. Twenty adult recipients of the Osia 2 System were enrolled and followed up between 12 and 24 months post-implantation: 17 with mixed or conductive hearing loss and 3 with single-sided sensorineural deafness. Safety data, audiological thresholds, speech recognition thresholds in noise, and patient-reported outcomes were collected and evaluated. In addition, pre-and 6-month post-implantation data were collected retrospectively for this recipient cohort enrolled into the earlier study (ClinicalTrials.gov NCT04041700). RESULTS: Between 6- and 24-month follow-up, there was no statistically significant change in free-field hearing thresholds or speech reception thresholds in noise (p = > 0.05), indicating that aided improvements were maintained up to 24 months of follow-up. Furthermore, improvements in health-related quality of life and daily hearing ability, as well as clinical and subjective measures of hearing benefit remained stable over the 24-month period. No serious adverse events were reported during extended follow-up. CONCLUSIONS: These study results provide further evidence to support the longer term clinical safety, hearing performance, and patient-related benefits of the Osia 2 System in patients with either a conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04754477. First posted: February 15, 2021.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Percepción del Habla / Sordera / Perdida Auditiva Conductiva-Sensorineural Mixta / Audífonos / Pérdida Auditiva / Pérdida Auditiva Sensorineural Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Humans Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Alemania
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Percepción del Habla / Sordera / Perdida Auditiva Conductiva-Sensorineural Mixta / Audífonos / Pérdida Auditiva / Pérdida Auditiva Sensorineural Tipo de estudio: Clinical_trials Aspecto: Patient_preference Límite: Adult / Humans Idioma: En Revista: Eur Arch Otorhinolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Alemania