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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
| Content Provider | Scilit |
|---|---|
| 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. |
| Copyright Year | 2020 |
| Description | Journal: Otology & Neurotology Objective(s): 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. |
| Related Links | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373438/pdf |
| Ending Page | 911 |
| Page Count | 11 |
| Starting Page | 901 |
| ISSN | 15317129 |
| e-ISSN | 15374505 |
| DOI | 10.1097/mao.0000000000002689 |
| Journal | Otology & Neurotology |
| Issue Number | 7 |
| Volume Number | 41 |
| Language | English |
| Publisher | Ovid Technologies (Wolters Kluwer Health) |
| Publisher Date | 2020-08-01 |
| Access Restriction | Open |
| Subject Keyword | Journal: Otology & Neurotology Otorhinolaryngology Attract, Baha, Bone Conduction, Bone Conduction Devices, Bone-anchored Hearing, Health Related Quality of Life, Hearing Loss, Implant Loss, Soft Tissue Reactions, Transcutaneous |
| Content Type | Text |
| Resource Type | Article |
| Subject | Otorhinolaryngology Sensory Systems Neurology (clinical) |
