title: Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial.
abstract: The objective of this study was to compare the stability, survival, and tolerability of 2 percutaneous osseointegrated titanium implants for bone conduction hearing: a 4.5-mm diameter implant (test) and a 3.75-mm diameter implant (control). Fifty-seven adult patients were included in this randomized controlled clinical trial. Sixty implants were allocated in a 2:1 (test-control) ratio. Follow-up visits were scheduled at 7, 14, 21, and 28 days; 6 and 12 weeks; and 6 months. At every visit, implant stability quotient (ISQ) values were recorded by means of resonance frequency analysis (RFA) and skin reactions were evaluated according to the Holgers classification. Implants were loaded with the bone conduction device at 3 weeks. Hearing-related quality of life was evaluated using the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Glasgow Benefit Inventory (GBI), and the Glasgow Health Status Inventory (GHSI). ISQ values were statistically significantly higher for the test implant compared to the control implant. No implants were lost and soft tissue reactions were comparable for both implants. Positive results were reported in the hearing-related quality of life questionnaires. These 6-month results indicate that both implants and their corresponding hearing devices are safe options for hearing rehabilitation in patients with the appropriate indications. Loading at 3 weeks did not affect the stability of either implant.
authors: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands. rik.nelissen@radboudumc.nl.
authors: Rik C
authors: RC
authors: Nelissen
authors: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
authors: Christine A
authors: CA
authors: den Besten
authors: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
authors: Emmanuel A M
authors: EA
authors: Mylanus
authors: Department of Otorhinolaryngology, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands.
authors: Myrthe K S
authors: MK
authors: Hol
mesh_terms: D003638:Deafness / Q000601:surgery; D005260:Female; D006310:Hearing Aids; D034381:Hearing Loss / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D016348:Osseointegration; D019736:Prostheses and Implants; D011788:Quality of Life; D014025:Titanium
chemical_list: D014025:Titanium
keywords: Baha; Bone conduction; Bone-anchored hearing aid; Bone-anchored hearing system; Early loading; Implant stability quotient (ISQ); Implant survival; Ponto; Quality of life; Resonance frequency analysis (RFA)