Authors' objectives: This health technology assessment looked at the effectiveness and safety of auditory brainstem implantation in adults with neurofibromatosis 2 or severe inner ear abnormalities (i.e., nontumour indications)who are not candidates for cochlear implantation. It also evaluated the budget impact of publicly funding auditory brainstem implantation and the experiences, preferences, and values of adults with neurofibromatosis 2 or severe inner ear abnormalities.

Authors' results and conclusions: Results We included 22 publications (16 in NF2, five in severe inner ear abnormalities, and one in complications of auditory brainstem implantation) in the clinical evidence review. In adults with NF2, auditory brainstem implantation when compared with no intervention allows any degree of improvement in sound recognition (GRADE:High), allows any degree of improvement in speech perception when used in conjunction with lip-reading (GRADE:High),and provides subjective benefits of hearing (GRADE:High). It likely allows any degree of improvement in speech perception when using the implant alone (GRADE:Moderate) and may improve quality of life (GRADE:Low). In adults with severe inner ear abnormalities, auditory brainstem implantation when compared with no intervention likely allows any degree of improvement in sound recognition (GRADE: Moderate) and in any speech perception when using the implant alone (GRADE: Moderate). It may allow any degree of improvement in speech perception when used in conjunction with lip-reading (GRADE: Low), provide subjective benefits of hearing (GRADE:Low), and improve quality of life (GRADE:Low). We did not identify any economic studies on auditory brainstem implantation for adults with NF2 or adults with deafness due to severe inner ear abnormalities. We estimated that the annual net budget impact of publicly funding auditory brainstem implantation in Ontario over the next 5 years would range from about $130,000i n year 1 for two procedures to about $260,000 in year 5 for four procedures. People with whom we spoke who had received an auditory brainstem implant reported that it restored some hearing ability and improved their quality of life, though they also reported ongoing challenges in using the device or side effects from the procedure. Conclusions When compared with no intervention, auditory brainstem implantation provides some benefit for completely deaf adults with NF2 or severe inner ear abnormalities who are not candidates for cochlear implantation. Based on evidence of moderate to high quality, auditory brainstem implants allow any degree of improvement in sound recognition and in speech perception when used in conjunction with lip-reading for people with NF2. The quality of evidence on these outcomes was low to moderate for people with severe inner ear abnormalities. These functional outcomes lead to subjective benefits of hearing which are consistently reported in the literature and in interviews with patients.We were unable to determine the cost-effectiveness of this treatment. We estimate that publicly funding auditory brainstem implantation in Ontario would result in additional costs of about $130,000 to $260,000 annually over the next 5 years.

Authors' recommendations: The Quality business unit at Ontario Health, based on guidance from the Ontario Health Technology Advisory Committee, recommends publicly funding:•Auditory brainstem implantation for adults with neurofibromatosis 2 who are not candidates for cochlear implantation•Auditory brainstem implantation for adults with severe inner ear abnormalities who are not candidates for cochlear implantation

Authors' methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Non-randomized Studies—of Interventions (ROBINS—I) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We did not conduct a primary economic evaluation because the outcomes identified in our clinical evidence review were difficult to translate into measures appropriate for health economic modelling. We also analyzed the net budget impact of publicly funding auditory brainstem implantation over the next 5 years in Ontario, including the device, presurgical assessment, surgical procedure, and postsurgical rehabilitation. To contextualize the potential value of auditory brainstem implants, we spoke with six people with lived experience of NF2 and severe inner ear abnormalities.

Project Status: Completed

URL for project: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/auditory-brainstem-implantation-for-adults-with-neurofibromatosis-2-or-severe-inner-ear-abnormalities

Year Published: 2020

URL for published report: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/auditory-brainstem-implantation-for-adults-with-neurofibromatosis-2-or-severe-inner-ear-abnormalities

Requestor: Ontario Health Technology Advisory Committee (OHTAC); Ontario Ministry of Health

URL for additional information: https://www.hqontario.ca/evidence-to-improve-care/health-technology-assessment/reviews-and-recommendations/auditory-brainstem-implantation-for-adults-with-neurofibromatosis-2-or-severe-inner-ear-abnormalities

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Ontario

Pubmed ID: 32190165

Organisation Name: Ontario Health

Contact Address: 525 University Ave, Toronto, ON M5G 2L3

Contact Name: Nancy Sikich, Director Health Technology Assessment

Contact Email: oh-hqo_hta@ontariohealth.ca

Copyright: © Queen’s Printer for Ontario, 2020 The copyright for all Ontario Health publications is owned by the Queen’s Printer for Ontario. Materials may be reproduced for commercial purposes only under a licence from the Queen’s Printer. For further information or to request a licence to reproduce content, please contact: Senior Copyright Advisor Publications Ontario 416-326-5153 copyright@ontario.ca