John T McElveen1, J Douglas Green2, Moises A Arriaga3, William H Slattery4. 1. Carolina Ear and Hearing Clinic, PC, Raleigh, North Carolina, USA. 2. Jacksonville Hearing and Balance Institute, Jacksonville, Florida, USA. 3. Department of Otolaryngology and Neurosurgery, Louisiana State University Medical School; Culicchia Neurological Clinic, New Orleans, Louisiana, USA. 4. House Ear Clinic, Los Angeles, California, USA.
Abstract
OBJECTIVES: To demonstrate the feasibility and efficacy for next-day loading of a percutaneous bone-anchored hearing device. STUDY DESIGN: Multicenter prospective cohort study. SETTING: Tertiary neurotologic referral centers. SUBJECT AND METHODS: In this multicenter prospective study, a 4.5-mm laser-etched bone-anchored hearing device was implanted in adult subjects who had conductive/mixed hearing loss or single-sided deafness. One day following implantation, the surgical site was assessed for soft tissue reaction per the Holgers Scale, and implant stability was evaluated by manual palpation and resonance frequency analysis. On the same day, subjects were fitted with the processor. Follow-up evaluations were at 1 week, 4 weeks, 3 months, 6 months, and 12 months. The Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires were completed postoperatively. RESULTS: Fourteen devices were implanted in 12 subjects. Two subjects underwent bilateral implantation. Implant stability was rated as firm at every interval for all ears, and the Implant Stability Quotient values at 3 months were stable or increased as compared with day 1 measurements. Skin irritation was limited to Holgers grade 0 and 1, with the majority having no skin irritation. The mean Glasgow Benefit Inventory global score was +43.8, and the mean Abbreviated Profile of Hearing Aid Benefit global benefit score was 60.2%. All 14 implants have remained firmly anchored. CONCLUSIONS: Next-day loading of this 4.5-mm-diameter percutaneous bone-anchored hearing device appears to be a feasible alternative to the original 3-month delayed loading. Although this is a preliminary study, the results support continued investigation of a next-day loading strategy.
OBJECTIVES: To demonstrate the feasibility and efficacy for next-day loading of a percutaneous bone-anchored hearing device. STUDY DESIGN: Multicenter prospective cohort study. SETTING: Tertiary neurotologic referral centers. SUBJECT AND METHODS: In this multicenter prospective study, a 4.5-mm laser-etched bone-anchored hearing device was implanted in adult subjects who had conductive/mixed hearing loss or single-sided deafness. One day following implantation, the surgical site was assessed for soft tissue reaction per the Holgers Scale, and implant stability was evaluated by manual palpation and resonance frequency analysis. On the same day, subjects were fitted with the processor. Follow-up evaluations were at 1 week, 4 weeks, 3 months, 6 months, and 12 months. The Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires were completed postoperatively. RESULTS: Fourteen devices were implanted in 12 subjects. Two subjects underwent bilateral implantation. Implant stability was rated as firm at every interval for all ears, and the Implant Stability Quotient values at 3 months were stable or increased as compared with day 1 measurements. Skin irritation was limited to Holgers grade 0 and 1, with the majority having no skin irritation. The mean Glasgow Benefit Inventory global score was +43.8, and the mean Abbreviated Profile of Hearing Aid Benefit global benefit score was 60.2%. All 14 implants have remained firmly anchored. CONCLUSIONS: Next-day loading of this 4.5-mm-diameter percutaneous bone-anchored hearing device appears to be a feasible alternative to the original 3-month delayed loading. Although this is a preliminary study, the results support continued investigation of a next-day loading strategy.
Authors: Max Sallis Osborne; Anne Child-Hymas; Marcus Holmberg; Peter Thomsen; Martin L Johansson; Ann-Louise McDermott Journal: Otol Neurotol Date: 2022-02-01 Impact factor: 2.311