Evaluation of the reimbursement for hearing aids and implants in hearing loss
Authors: Obyn Caroline , de Meester Christophe , Cornelis Justien 
Published: January 2025

1 INTRODUCTION .19 -- 1.1 CONTEXT, AIM AND RESEARCH QUESTIONS 19 -- 1.2 METHODS AND REPORT OUTLINE 20 -- 2 CLINICAL BACKGROUND 23 -- 2.1 PATHOLOGY AND CAUSES OF HEARING LOSS .23 -- 2.2 TYPES OF HEARING LOSS .23 -- 2.2.1 Sensorineural, conductive and mixed hearing loss 24 -- 2.2.2 Bilateral and unilateral hearing loss 24 -- 2.2.3 Prelingual and postlingual deafness 24 -- 2.2.4 The special case of auditory neuropathy .25 -- 2.3 CATEGORISATION OF HEARING DEVICES: HEARING AIDS AND IMPLANTS 28 -- 2.3.1 Conventional hearing aid (CHA) 28 -- 2.3.2 Bone conduction hearing device (BCD) 28 -- 2.3.3 Middle ear implant (MEI) 31 -- 2.3.4 Cochlear implant (CI) .32 -- 2.3.5 Auditory Brainstem Implant .32 -- 2.4 INDICATIONS AND TREATMENT OPTIONS BY PATHOLOGY 32 -- 2.4.1 Sensorineural hearing loss (SNHL) 32 -- 2.4.2 Conductive hearing loss (CHL) .33 -- 2.4.3 Mixed hearing loss (MHL) 33 -- 2.4.4 Single sided deafness (SSD) and asymmetrical hearing loss (AHL) .34 -- 3 REIMBURSEMENT OF HEARING AIDS AND IMPLANTS IN BELGIUM 34 -- 3.1 DECISION-MAKING AT RIZIV-INAMI 34 -- 3.2 REIMBURSED DEVICES 35 -- 3.3 REIMBURSED INDICATIONS .37 -- 3.3.1 Conventional hearing aids 37 -- 3.3.2 Implantable part of the bone conduction devices 39 -- 3.3.3 Middle Ear Implants 39 -- 3.3.4 Cochlear Implants 42 -- 3.3.5 Exceptional reimbursement by Special Solidarity Fund 46 -- 3.4 REIMBURSEMENT FEES AND OUT-OF-POCKET EXPENDITURES 46 -- 3.4.1 Conventional hearing aids and the sound processor of bone conduction devices .46 -- 3.4.2 Implantable part of bone conduction devices 47 -- 3.4.3 Middle Ear Implants 47 -- 3.4.4 Cochlear Implants 47 -- 3.5 CONDITIONS IMPOSED TO THE IMPLANTING UNITS 48 -- 3.5.1 Middle Ear Implants 48 -- 3.5.2 Cochlear Implants 48 -- 3.6 CONDITIONS FOR THE IMPLANTS 48 -- 3.6.1 Middle Ear Implants 48 -- 3.6.2 Cochlear Implants 49 -- 4 CLINICAL EVIDENCE .49 -- 4.1 RESEARCH QUESTIONS .49 -- 4.2 METHODOLOGY 50 -- 4.2.1 Search strategy .50 -- 4.2.2 Data to retrieve 52 -- 4.3 RESULTS OF THE SYSTEMATIC SEARCH 52 -- 4.4 ANSWERING THE RESEARCH QUESTIONS: RESULTS OF THE LITERATURE SEARCH 53 -- 4.4.1 Clinical effectiveness of active transcutaneous bone conduction implants. 53 -- 4.4.2 Clinical effectiveness of bilateral CI (compared to unilateral CI) in bilateral hearing loss in adults. .55 -- 4.4.3 Clinical effectiveness of cochlear implant and other hearing solutions in single sided deafness with or without tinnitus 56 -- 4.4.4 Clinical effectiveness of fully implanted middle ear implants and traditional semi-implanted MEIs .65 -- 4.4.5 Complications, safety and adverse events of hearing implants. 66 -- 5 ECONOMIC REVIEW AND COST-CONSEQUENCES ANALYSIS IN BELGIAN SETTING .69 -- 5.1 LITERATURE SEARCH 69 -- 5.1.1 Research questions 69 -- 5.1.2 Selection criteria 70 -- 5.1.3 Search strategy .70 -- 5.2 RESULTS OF THE LITERATURE SEARCH 73 -- 5.2.2 General characteristics of included economic studies 74 -- 5.3 DESCRIPTION AND DISCUSSION OF THE ECONOMIC STUDIES .77 -- 5.3.1 Cost-effectiveness results and thresholds applied .77 -- 5.3.2 Utility results and instruments used 82 -- 5.3.3 Costs 91 -- 5.4 COST-CONSEQUENCE ANALYSIS IN A BELGIAN SETTING .93 -- 5.4.1 Long-term incremental costs for (sequential or simultaneous) BCI compared to UCI or bimodal treatment 93 -- 5.4.2 Long-term incremental costs for CI in SSD compared to unaided or treatment with CROS or BCD 94 -- 5.4.3 Incremental long-term costs for active tBCD in SSD / mixed and conductive hearing loss 94 -- 5.5 CONCLUSIONS 95 -- 6 DATA ANALYSIS 98 -- 6.1 INTRODUCTION .98 -- 6.2 DATA SOURCES 98 -- 6.2.1 Document N data .98 -- 6.2.2 Minimal Hospital data: 98 -- 6.2.3 Administrative data from the Intermutualistic Agency 99 -- 6.3 RIZIV-INAMI BUDGET FOR HEARING AIDS AND HEARING IMPLANTS .99 -- 6.4 AMOUNT OF REIMBURSED HEARING DEVICES DURING THE YEARS 2014 UP TO 2018 IN BELGIUM .100 -- 6.4.1 Conventional hearing aids 100 -- 6.4.2 Bone conduction devices 101 -- 6.4.3 Cochlear implants .102 -- 6.4.4 Middle Ear Implants .103 -- 6.5 AMOUNT OF PATIENTS WITH HEARING AIDS OR IMPLANTS .103 -- 6.5.1 Conventional hearing aids 103 -- 6.5.2 Hearing implants 103 -- 6.6 REIMBURSED COSTS OF THE DIFFERENT IMPLANTATION PHASES 106 -- 6.6.1 Procedural phase 106 -- 6.6.2 Pre- and postprocedural phase 109 -- 6.7 DISTRIBUTION OF THE DELIVERED HEARING AIDS AND IMPLANTS IN BELGIUM AND THE PLACE OF IMPLANTATION 113 -- 6.7.1 Accessibility 113 -- 6.7.2 Place of implantation 113 -- 7 INTERNATIONAL COMPARISON .115 -- 7.1 INTRODUCTION 115 -- 7.2 METHODS 115 -- 7.3 SELECTION OF COUNTRIES 115 -- 7.4 NETHERLANDS 116 -- 7.4.1 Cochlear Implants .116 -- 7.4.2 Middle Ear Implants .121 -- 7.4.3 Bone Conduction Devices .121 -- 7.5 FRANCE 122 -- 7.5.1 Cochlear Implants .122 -- 7.5.2 Middle Ear Implants .126 -- 7.5.3 Bone Conduction Devices .126 -- 7.6 GERMANY 127 -- 7.6.1 Cochlear Implants .127 -- 7.6.2 Bone Conduction Devices and Middle Ear Implants 129 -- 7.7 SWITZERLAND .130 -- 7.7.1 Cochlear Implants .130 -- 7.7.2 Middle Ear Implants .132 -- 7.7.3 Bone Conduction Devices .132 -- 7.8 SPAIN .132 -- 7.8.1 Cochlear Implants .132 -- 7.8.2 Middle Ear Implants .137 -- 7.8.3 Bone Conduction Devices .137 -- 7.9 NHS ENGLAND .138 -- 7.9.1 Cochlear Implants .138 -- 7.9.2 Bone Conduction Devices .140 -- 7.9.3 Middle Ear Implants .141 -- 7.10 CANADA  ONTARIO 141 -- 7.10.1 Cochlear Implants .141 -- 7.10.2 Bone conduction devices and middle ear implants 143 -- 7.11 CANADA  QUEBEC .143 -- 7.11.1 Cochlear Implants .143 -- 7.12 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR CI 144 -- 7.12.1 Approaches in the reimbursement of CI 144 -- 7.12.2 Reimbursed/Guideline indications for CI 146 -- 7.12.3 Volume of CI per newborn and inhabitant 154 -- 7.12.4 Pricing of CI 156 -- 7.12.5 Registration of CI patients .156 -- 7.12.6 Upgrade term for sound processor 157 -- 7.13 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR BCD .157 -- 7.14 CROSS-COUNTRY COMPARISON AND KEY POINTS FOR MEI 158 -- 8 LIST OF OPTIONS AND EVALUATION OF EACH OPTION 158 -- 8.1 REIMBURSEMENT OF CONVENTIONAL HEARING AIDS .159 -- 8.2 REIMBURSEMENT OF BONE CONDUCTION DEVICES .159 -- 8.2.1 Increased reimbursement for the non-implantable bone conduction devices 160 -- 8.2.2 Reimbursement of the implantable part of passive transcutaneous and percutaneous bone conduction devices 161 -- 8.2.3 Reimbursement of active transcutaneous bone conduction devices 161 -- 8.2.4 Adaptation of hearing gain test for bone conduction devices in children 165 -- 8.2.5 Ensure that the mandatory trial period for BCD is complied to 165 -- 8.3 REIMBURSEMENT OF MEI 166 -- 8.4 REIMBURSEMENT OF CI 167 -- 8.4.1 Expansion of reimbursement to bilateral CI in patients above 12 years: according to selected criteria 167 -- 8.4.2 Expansion of reimbursement for CI in SSD: according to selected criteria .170 -- 8.4.3 Minor adaptation of the criteria for CI implantation 175 -- 8.4.4 Modification or elaboration of tests for CI .177 -- 8.4.5 Facilitation and quality-assurance of fitting and rehabilitation for CI 177 -- 8.5 CONDITIONS IMPOSED TO CENTRES .180 -- 8.5.1 Towards networking for quality assurance 180 -- 8.5.2 A Belgian or international registry for hearing implants? 185 -- 8.5.3 Precise rules versus more flexibility in criteria? (a topic linked to organisation of care) 185 -- 8.6 EXPANSION OF REIMBURSEMENT  VARIOUS OPTIONS RAISED BY THE EXPERTS 186 -- 8.6.1 Expansion of reimbursement for frequency modulation (FM) systems for unilateral hearing loss? 186 -- 8.6.2 Creation of nomenclature for facialis monitoring? 187 -- 8.6.3 Public availability of Bluetooth protocols 187 -- 8.6.4 Harmonization of payment for simultaneous as well as sequential cochlear implantation 187 -- APPENDICES 188