TY - JOUR
T1 - Unilateral cochlear implants for severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss a systematic review and consensus statements
AU - Buchman, Craig A.
AU - Gifford, René H.
AU - Haynes, David S.
AU - Lenarz, Thomas
AU - O'Donoghue, Gerard
AU - Adunka, Oliver
AU - Biever, Allison
AU - Briggs, Robert J.
AU - Carlson, Matthew L.
AU - Dai, Pu
AU - Driscoll, Colin L.
AU - Francis, Howard W.
AU - Gantz, Bruce J.
AU - Gurgel, Richard K.
AU - Hansen, Marlan R.
AU - Holcomb, Meredith
AU - Karltorp, Eva
AU - Kirtane, Milind
AU - Larky, Jannine
AU - Mylanus, Emmanuel A.M.
AU - Thomas Roland, J.
AU - Saeed, Shakeel R.
AU - Skarzynski, Henryk
AU - Skarzynski, Piotr H.
AU - Syms, Mark
AU - Teagle, Holly
AU - van de Heyning, Paul H.
AU - Vincent, Christophe
AU - Wu, Hao
AU - Yamasoba, Tatsuya
AU - Zwolan, Terry
N1 - Funding Information:
Funding/Support: Funding for this study was provided by Advanced Bionics, Cochlear Ltd, MED-EL, and Oticon Medical. Support with consensus statement development and Delphi consensus voting rounds was provided by Oxford PharmaGenesis (an independent health science communications consultancy providing services to the health care industry), professional societies, and patient groups through specialist practices.
Funding Information:
US9,072,468B2; and owning stock in Advanced Cochlear Diagnostics LLC. Dr Gifford reported being a consultant for Advanced Bionics and Cochlear Ltd, serving on the clinical advisory board for Frequency Therapeutics, being a member of the board of directors for the American Auditory Society, and receiving grant funding from the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health. Dr Haynes reported being a consultant for Advanced Bionics, Cochlear Ltd, MED-EL, Stryker, and Synthese. Dr Lenarz reported having collaborative projects with Advanced Bionics, Cochlear Ltd, MED-EL, and Oticon Medical. Dr Adunka reported receiving personal fees from Advanced Bionics and having a patent to US9,380,962 issued, licensed, and with royalties paid. Dr Biever reported being a consultant for the American Speech-Language-Hearing Association, Cochlear Ltd, and the Institute for Cochlear Implant Training (ICIT) and receiving personal fees from Cochlear Americas. Dr Briggs reported being a consultant for Cochlear Ltd. Dr Carlson reported having a patent to USWO2017213978 pending. Dr Driscoll reported receiving grants and personal fees from Advanced Bionics and Cochlear Ltd and receiving personal fees from Envoy Medical and Stryker. Dr Francis reported being a member of the surgical advisory boards for Advanced Bionics and MED-EL and receiving a grant from Advanced Bionics. Dr Gantz reported being a consultant for Cochlear Ltd and having a patent issued for the Hybrid cochlear implant. Dr Gurgel reported receiving personal fees from and serving on the surgical advisory board for MED-EL, receiving funding from the National Institutes of Health, and being employed by University of Utah Hospital, which has received grants from Advanced Bionics and Cochlear Ltd. Dr Hansen reported being a cofounder of and having equity interest in iotaMotion. Dr Holcomb reported being a consultant to and serving on the audiology advisory boards of Advanced Bionics and MED-EL, receiving personal speaker fees as a consultant for the American Speech-Language-Hearing Association, receiving personal speaker fees from Audiology Online, serving on the board of directors for the American Cochlear Implant Alliance (ACI Alliance), receiving travel support from Cochlear Ltd, being a consultant for the ICIT, receiving grants from Advanced Bionics and MED-EL, and receiving support for the ICIT from Cochlear Corporation and the Institute for Cochlear Implant Training. Dr Karltorp reported serving on the advisory board for MED-EL. Dr Larky reported serving on the board of directors for the ACI Alliance and receiving personal fees from Envoy Medical. Dr Mylanus reported being employed by Radboud University Medical Centre, which has received grants from Advanced Bionics and Cochlear Ltd, and receiving personal fees for teaching services from Cochlear Ltd. Dr Roland reported being a consultant for and advisory board member of Cochlear Americas and receiving research support from Advanced Bionics,
Funding Information:
Cochlear Ltd, and MED-EL. Dr Saeed reported receiving consultancy fees from Cochlear Ltd. Dr Syms reported received funding for travel from and being a shareholder in a pension plan with Cochlear Ltd, serving on the advisory board for and being an equity holder for Earlens, and receiving personal fees from Earlens and Zeiss. Dr Teagle reported serving on advisory boards for Advanced Bionics, Cochlear Ltd, and MED-EL; and receiving funding for travel from Cochlear Ltd. Dr Van de Heyning reported receiving funding for conference fees and travel and education grants from MED-EL and being employed by Antwerp University Hospital, which has received research grants from Cochlear Ltd and MED-EL. Dr Yamasoba reported receiving an honorarium from Cochlear Ltd. Dr Zwolan reported receiving grant funding from and being a consultant and advisory board member for Cochlear Americas and being an advisory board member for Envoy Medical. No other disclosures were reported.
Funding Information:
reported serving as a consultant for Advanced Bionics, Cochlear Ltd, IotaMotion, and Envoy; receiving research support from Advanced Bionics, Cochlear Ltd, and MedEL; obtaining grants from the US Department of Defense; having a patent to
Publisher Copyright:
© 2020 American Medical Association. All rights reserved.
PY - 2020/10
Y1 - 2020/10
N2 - IMPORTANCE Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine. OBJECTIVE To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL. DESIGN, SETTING, AND PARTICIPANTS This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019. MAIN OUTCOMES AND MEASURES A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting. RESULTS In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement). CONCLUSIONS AND RELEVANCE These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.
AB - IMPORTANCE Cochlear implants are a treatment option for individuals with severe, profound, or moderate sloping to profound bilateral sensorineural hearing loss (SNHL) who receive little or no benefit from hearing aids; however, cochlear implantation in adults is still not routine. OBJECTIVE To develop consensus statements regarding the use of unilateral cochlear implants in adults with severe, profound, or moderate sloping to profound bilateral SNHL. DESIGN, SETTING, AND PARTICIPANTS This study was a modified Delphi consensus process that was informed by a systematic review of the literature and clinical expertise. Searches were conducted in the following databases: (1) MEDLINE In-Process & Other Non-Indexed Citations and Ovid MEDLINE, (2) Embase, and (3) the Cochrane Library. Consensus statements on cochlear implantation were developed using the evidence identified. This consensus process was relevant for the use of unilateral cochlear implantation in adults with severe, profound, or moderate sloping to profound bilateral SNHL. The literature searches were conducted on July 18, 2018, and the 3-step Delphi consensus method took place over the subsequent 9-month period up to March 30, 2019. MAIN OUTCOMES AND MEASURES A Delphi consensus panel of 30 international specialists voted on consensus statements about cochlear implantation, informed by an SR of the literature and clinical expertise. This vote resulted in 20 evidence-based consensus statements that are in line with clinical experience. A modified 3-step Delphi consensus method was used to vote on and refine the consensus statements. This method consisted of 2 rounds of email questionnaires and a face-to-face meeting of panel members at the final round. All consensus statements were reviewed, discussed, and finalized at the face-to-face meeting. RESULTS In total, 6492 articles were identified in the searches of the electronic databases. After removal of duplicate articles, 74 articles fulfilled all of the inclusion criteria and were used to create the 20 evidence-based consensus statements. These 20 consensus statements on the use of unilateral cochlear implantation in adults with SNHL were relevant to the following 7 key areas of interest: level of awareness of cochlear implantation (1 consensus statement); best practice clinical pathway from diagnosis to surgery (3 consensus statements); best practice guidelines for surgery (2 consensus statements); clinical effectiveness of cochlear implantation (4 consensus statements); factors associated with postimplantation outcomes (4 consensus statements); association between hearing loss and depression, cognition, and dementia (5 consensus statements); and cost implications of cochlear implantation (1 consensus statement). CONCLUSIONS AND RELEVANCE These consensus statements represent the first step toward the development of international guidelines on best practices for cochlear implantation in adults with SNHL. Further research to develop consensus statements for unilateral cochlear implantation in children, bilateral cochlear implantation, combined electric-acoustic stimulation, unilateral cochlear implantation for single-sided deafness, and asymmetrical hearing loss in children and adults may be beneficial for optimizing hearing and quality of life for these patients.
UR - http://www.scopus.com/inward/record.url?scp=85092222902&partnerID=8YFLogxK
U2 - 10.1001/jamaoto.2020.0998
DO - 10.1001/jamaoto.2020.0998
M3 - Review article
C2 - 32857157
AN - SCOPUS:85092222902
SN - 2168-6181
VL - 146
SP - 942
EP - 953
JO - JAMA Otolaryngology - Head and Neck Surgery
JF - JAMA Otolaryngology - Head and Neck Surgery
IS - 10
ER -