PURPOSE

The purpose of this study is to assess implant stability, implant loss, adverse skin reactions and quality of life benefit following surgical implantation and early processor loading (3-weeks post-implantation) of the Oticon Ponto 4.5 mm osseointegrated auditory implant. This study also investigates the relationship between the type of post-operative skin reactions and the gender, BMI and medical co-morbidities of participants.

MATERIALS/METHODS: Using a prospective, multicenter design, thirty adult patients 18 years or older who met medical and audiological candidacy for an osseointegrated auditory bone-anchored hearing device were evaluated. They underwent simultaneous implantation of the Oticon 4.5mm wide implant and a 3.75 mm sleeper implant. Sound processor loading occurred at three weeks post-implantation. Implant stability was measured using Radio Frequency Analysis (RFA) at surgery, 1, 3, 6, 12, 26 and 52 weeks. The Glasgow Benefit Inventory was used to assess quality of life benefit at 12 and 52 weeks following implantation.

RESULTS

The results show a positive linear trend in implant stability measures in all subjects over time. There have been no implant losses with early 3-week loading. Skin reactions were limited to grade 0 and 1 of the modified Holger's grading scale. Due to the limited incidence of complications, no conclusion can be made regarding the relationship between patient demographic data and soft tissue reaction.

CONCLUSION

Our findings confirm the safety and efficacy of early loading of the Oticon 4.5 mm wide implant. Participants showed satisfaction with the earlier use of their processor with no added complications after one year post-implantation.