Faculty Collaboration Database

Results of a 2-Year Prospective Multicenter Study Evaluating Long-term Audiological and Clinical Outcomes of a Transcutaneous Implant for Bone Conduction Hearing. Otol Neurotol 2020 Aug;41(7):901-911

Date

04/21/2020

Pubmed ID

32310837

Pubmed Central ID

PMC7373438

DOI

10.1097/MAO.0000000000002689

Scopus ID

2-s2.0-85088486999 (requires institutional sign-in at Scopus site)   6 Citations

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.

Author List

Kruyt IJ, Monksfield P, Skarzynski PH, Green K, Runge C, Bosman A, Blechert JI, Wigren S, Mylanus EAM, Hol MKS

Author

Christina Runge PhD Associate Provost, Chief, Professor in the Otolaryngology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Bone Conduction
Hearing Aids
Hearing Loss, Conductive
Hearing Loss, Mixed Conductive-Sensorineural
Humans
Prospective Studies
Treatment Outcome