Stability, survival, and tolerability of a 4.5-mm-wide bone-anchored hearing implant: 6-month data from a randomized controlled clinical trial

Rik C Nelissen, Christine A den Besten, Emmanuel A M Mylanus, Myrthe K S Hol, Rik C Nelissen, Christine A den Besten, Emmanuel A M Mylanus, Myrthe K S Hol

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.

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).

Figures

Fig. 1
Fig. 1
Control (a) and test (b) implants with abutments
Fig. 2
Fig. 2
Box-and-whisker plots of ISQ low and ISQ high measurements. The mean (cross) and median (horizontal line) are defined within each box plot. Dots represent outlier values
Fig. 3
Fig. 3
Soft tissue tolerability for test and control groups as a percentage of all visits according to the Holgers classification. Note that only Holgers grade 0–3 are depicted, as no Holgers grade 4 was observed
Fig. 4
Fig. 4
Subjective benefit as measured by the APHAB and GHSI questionnaires, completed before surgery and after 6 months of follow-up. The subscales of the APHAB are represented by the abbreviations on the x axis: EC ease of communication, BN background noise, RV reverberation, and AV aversiveness of sounds

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Source: PubMed

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