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Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing
To evaluate 2-year audiological and clinical outcomes of a transcutaneous implant for bone conduction hearing of a previously published 6-month evaluation. DESIGN: Fifty-four unilaterally implanted adult patients with conductive or mild mixed hearing loss or single-sided sensorineural deafness were...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373438/ https://www.ncbi.nlm.nih.gov/pubmed/32310837 http://dx.doi.org/10.1097/MAO.0000000000002689 |
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author | Kruyt, Ivo J. Monksfield, Peter Skarzynski, Piotr H. Green, Kevin Runge, Christina Bosman, Arjan Blechert, Johan I. Wigren, Stina Mylanus, Emmanuel A. M. Hol, Myrthe K. S. |
author_facet | Kruyt, Ivo J. Monksfield, Peter Skarzynski, Piotr H. Green, Kevin Runge, Christina Bosman, Arjan Blechert, Johan I. Wigren, Stina Mylanus, Emmanuel A. M. Hol, Myrthe K. S. |
author_sort | Kruyt, Ivo J. |
collection | PubMed |
description | To evaluate 2-year audiological and clinical outcomes of a transcutaneous implant for bone conduction hearing of a previously published 6-month evaluation. DESIGN: Fifty-four unilaterally implanted adult patients with conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in this prospective multicenter study. Follow-up visits were scheduled post-surgery at 10 days; 4, 6, and 12 weeks; 6, 12, and 24 months. Main outcomes were audiological benefit, patient-reported outcomes (PROs), soft tissue status, pain, numbness, implant survival, and daily usage. RESULTS: In the study population, the transcutaneous implant resulted in statistically significant improvement in objective hearing test and PROs compared with the unaided situation. Soft tissue complications were observed in 4.6% of the patients per visit. Pain/discomfort and numbness were initially reported in the majority of the patients, but declined over time; approximately 9% of patients reported some degree of numbness and 15% (slight) pain/discomfort after 2 years. During the 24-month period, two implant magnets were removed (3.7%), while two other implants were converted to the percutaneous counterpart (3.7%). At the final visit, 89.6% (n = 42 out of 47) of the patients used their sound processor, with a median daily usage of 6 h/d (range, 0–18 h/d). CONCLUSIONS: After 24 months, the transcutaneous implant provided statistically significant mean improvement in objective and subjective hearing performance as well as PROs compared with the preoperative unaided condition and had a low soft tissue complication rate. The test device could be considered as an alternative treatment option for appropriately selected and counseled patients. |
format | Online Article Text |
id | pubmed-7373438 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-73734382020-08-05 Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing Kruyt, Ivo J. Monksfield, Peter Skarzynski, Piotr H. Green, Kevin Runge, Christina Bosman, Arjan Blechert, Johan I. Wigren, Stina Mylanus, Emmanuel A. M. Hol, Myrthe K. S. Otol Neurotol Audiology To evaluate 2-year audiological and clinical outcomes of a transcutaneous implant for bone conduction hearing of a previously published 6-month evaluation. DESIGN: Fifty-four unilaterally implanted adult patients with conductive or mild mixed hearing loss or single-sided sensorineural deafness were included in this prospective multicenter study. Follow-up visits were scheduled post-surgery at 10 days; 4, 6, and 12 weeks; 6, 12, and 24 months. Main outcomes were audiological benefit, patient-reported outcomes (PROs), soft tissue status, pain, numbness, implant survival, and daily usage. RESULTS: In the study population, the transcutaneous implant resulted in statistically significant improvement in objective hearing test and PROs compared with the unaided situation. Soft tissue complications were observed in 4.6% of the patients per visit. Pain/discomfort and numbness were initially reported in the majority of the patients, but declined over time; approximately 9% of patients reported some degree of numbness and 15% (slight) pain/discomfort after 2 years. During the 24-month period, two implant magnets were removed (3.7%), while two other implants were converted to the percutaneous counterpart (3.7%). At the final visit, 89.6% (n = 42 out of 47) of the patients used their sound processor, with a median daily usage of 6 h/d (range, 0–18 h/d). CONCLUSIONS: After 24 months, the transcutaneous implant provided statistically significant mean improvement in objective and subjective hearing performance as well as PROs compared with the preoperative unaided condition and had a low soft tissue complication rate. The test device could be considered as an alternative treatment option for appropriately selected and counseled patients. Lippincott Williams & Wilkins 2020-08 2020-04-16 /pmc/articles/PMC7373438/ /pubmed/32310837 http://dx.doi.org/10.1097/MAO.0000000000002689 Text en Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc. http://creativecommons.org/licenses/by-nc-nd/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0 |
spellingShingle | Audiology Kruyt, Ivo J. Monksfield, Peter Skarzynski, Piotr H. Green, Kevin Runge, Christina Bosman, Arjan Blechert, Johan I. Wigren, Stina Mylanus, Emmanuel A. M. Hol, Myrthe K. S. Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title | Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title_full | Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title_fullStr | Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title_full_unstemmed | Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title_short | Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing |
title_sort | results of a 2-year prospective multicenter study evaluating long-term audiological and clinical outcomes of a transcutaneous implant for bone conduction hearing |
topic | Audiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373438/ https://www.ncbi.nlm.nih.gov/pubmed/32310837 http://dx.doi.org/10.1097/MAO.0000000000002689 |
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