Anatomical, functional and quality-of-life results for mastoid and epitympanic obliteration with bioactive glass s53p4: a prospective clinical study

Objective To analyse the anatomical, functional and quality‐of‐life results when using bioactive glass in mastoid and epitympanic obliteration. Design Prospective clinical study. Setting Tertiary referral centre. Participants Forty‐one cases (39 patients) operated between May 2013 and January 2015. Main outcome measures Anatomical results were evaluated by otomicroscopy 1 year after surgery and using imaging to detect residual disease. Functional results were studied by postoperative hearing gain. Quality of life was assessed with the Glasgow Benefit Inventory questionnaire and the success of surgery by a surgery‐specific questionnaire. Results At 1 year, all patients presented a well‐healed external auditory canal, with an intact tympanic membrane. In cases with cholesteatoma (n = 23), no recurrent retraction pockets or residual disease were observed on imaging studies. The overall air–bone gap closure was 7.7 ± 1.84 dB (mean ± se of the mean, P < 0.001, paired t‐test). No significant differences were found on hearing results when comparing primary versus revision surgery, canal‐wall‐up versus canal‐wall‐down obliterations, type of tympanoplasty and presence of cholesteatoma (multifactor anova). The Glasgow Benefit Inventory improved with an average score of 28 and the success of surgery questionnaire showed a significant improvement in ear discharge and a moderate improvement in hearing and equilibrium. Conclusions The use of bioactive glass for mastoid and epitympanic obliteration in canal‐wall‐down or canal‐wall‐up tympanoplasties is an effective procedure in both primary and revision surgery. The anatomical and functional results appear to be well correlated with patient experience and to the improvement in quality of life