3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 10 sources, which was discussed by the committee. The evidence included 2 randomised controlled trials (both of which had longer follow up reported in separate papers), 2 systematic reviews and 4 case series (1 of which was also included in the systematic reviews). It is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: improvement in symptoms, disease-specific quality-of-life scores and physiological measures of eustachian tube function.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: pain and patulous eustachian tube.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that the procedure was not effective in all patients, and that there was little evidence on the benefit of repeat procedures.
3.6 The committee was informed that the procedure is only indicated for chronic eustachian tube dysfunction refractory to medical treatment.