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Bioglass middle ear prosthesis: long-term results
K R Rust1, G T Singleton, J Wilson
1Department of Otolaryngology, University of Florida, Gainesville 32610, USA.
The American Journal of Otology
|May 1, 1996
Summary
Bioglass middle ear prostheses show excellent long-term tissue compatibility and stable hearing results in patients. Early device fractures were identified as the cause of the few failures in this study.
Area of Science:
- Biomaterials Science
- Otolaryngology
- Medical Device Engineering
Background:
- Bioglass prostheses have been utilized for middle ear reconstruction.
- Long-term outcomes and tissue compatibility require thorough evaluation.
Purpose of the Study:
- To review the University of Florida's long-term results with Bioglass middle ear prostheses.
- To assess the efficacy and safety of these devices in patients undergoing ossicular reconstruction.
Main Methods:
- Retrospective review of 37 patients implanted with Bioglass prostheses (total and partial ossicular replacements) between 1984 and 1987.
- Analysis of postoperative data, including audiological outcomes (air-bone gap) and device integrity, with follow-up ranging up to 126 months.
Main Results:
- Twenty-one patients had at least 24 months of follow-up; five had over 10 years.
- Four device failures occurred, attributed to fractures in early prototypes; no extrusions of intact prostheses were observed.
- Mean air-bone gap after 24 months was 24 dB, with 53% of patients achieving an air-bone gap of 20 dB or less. Hearing results remained stable over time.
Conclusions:
- Bioglass middle ear prostheses demonstrate excellent long-term tissue compatibility.
- The study highlights the importance of device design, with early prototype fractures being the primary cause of failure.
- Bioglass prostheses are a viable option for middle ear reconstruction, offering stable audiological outcomes.