Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing. Issue 7 (August 2020)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Otology & neurotology. Volume 41:Issue 7(2020)
• Publication Date: 2020-08
• Subjects: Attract -- Baha -- Bone conduction -- Bone conduction devices -- Bone-anchored hearing -- Health related quality of life -- Hearing loss -- Implant loss -- Soft tissue reactions -- Transcutaneous; Otology -- Periodicals; Ear -- Diseases -- Periodicals; Skull base -- Surgery -- Periodicals; 617.8005
• DOI: 10.1097/MAO.0000000000002689
• Languages: English
• ISSNs: 1531-7129

Abstract

Abstract : 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.