Product Narrative: Hearing Aids
i
ii
ACKNOWLEDGEMENTS
iii
TABLE OF CONTENTS
iv
ACRONYMS
1
EXECUTIVE SUMMARY
2
3
INTRODUCTION
1. Assistive Technology and Market Shaping
4
2. Product Narrative
5
CHAPTER 1: MARKET LANDSCAPE
3. Market Context
3.1. Globally 466 million people have disabling hearing loss; this number is expected to double by 2050 due to ageing populations, and new cases of hearing loss caused by untreated ear infections, ototoxicity, and noise exposure.
6
3.2. W.H.O. estimates that 72 million people worldwide need hearing aids, but current coverage of hearing aids meets less than 3% of need in L.M.I.C.s.16
7
8
3.3. Unaddressed hearing loss has a profound effect on individuals, and hearing aids can assist to counteract negative effects.
9
3.4. Experts recommend that hearing aids should be provided within the context of a broader Ear and Hearing Care programme, but multiple implementation challenges exist.
10
3.5. Provision of hearing aids generally includes the following steps: 1) screening for and diagnosing hearing loss; 2) selecting and fitting appropriate hearing aids; and 3) providing long-term follow-up and rehabilitation services to the user.
11
3.6. W.H.O. global guidelines related to hearing aid provision in low-resource settings (L.R.S.) are outdated and lack specificity, which has led to a variety of approaches to hearing aid provision.
12
3.7. While different types of hearing aids exist in the market, specific hearing aids appropriate for the L.M.I.C. context are described by the W.H.O. P.P.P..
13
14
3.8. No global standard for quality testing currently exists to differentiate quality hearing aids from poor quality products.
3.9. Donor funding for procurement and provision of hearing aids in L.M.I.C.s is limited and often comes from C.S.R. programmes of leading suppliers.
15
4. Market Assessment
4.1. The global hearing aids market focuses on high-income markets and is consolidated around five major manufacturers who control the value chain.
16
4.2. The Big 5 are focused on premium products to generate market value and have limited commercial interest in L.M.I.C.s.
17
4.3. To meet the needs of lower-income market segments, approaches exist in the private sector that can deliver quality hearing aids in more affordable ways to the end-user.
18
4.4. In the absence of a global standard, quality products struggle to compete in unregulated markets as many low-cost suppliers have emerged that have products of variable or unknown quality.
4.5. National health insurance systems in H.I.C.s have been able to increase adoption rates, sustainably deliver services and reduce prices obtained on Big 5 models through volume-based negotiation.
19
4.6. While there is potential to increase adoption of affordable and quality hearing aids, there is currently a considerable lack of effective public procurement in L.M.I.C.s.
20
4.7. N.G.O.s have found ways to access quality hearing aids at an affordable rate and provide cost-effective services, pointing to potential approaches that L.M.I.C. governments could use to access affordable, quality products.
21
4.8. There is limited scope to optimise or relocate manufacturing to generate additional cost reductions in the price of hearing aids.
22
4.9. The advent of new technologies for hearing loss screening and diagnosis and hearing aid fitting may address service delivery capacity constraints and create opportunities to reach more people.
4.9.1. Otoscopes
23
4.9.2. Audiometers
24
4.9.3. Tele-audiology
25
4.9.4. Earmould innovations
4.9.5. Rechargeable Batteries
4.10. Innovative models of hearing aids have the potential to facilitate greater access to hearing aids in L.M.I.C.s.
4.10.1. O.T.C. (Over the Counter) hearing aid regulations in the United States
26
4.10.2. Self-fitting hearing aid models
4.10.3. Pre-programmable hearing aids
27
5. Market Challenges
28
29
30
CHAPTER 2: STRATEGIC APPROACH TO MARKET SHAPING
6. Strategic Approach to Market Shaping
31
Strategic Objective 1: Strengthen global policy guidance around service delivery, product selection and product quality
32
Strategic Objective 2: Support L.M.I.C. governments to strengthen hearing aid provision including demand generation and investing in service delivery capacity, government purchasing and procurement support
33
Strategic Objective 3: Engage the private sector to expand delivery of affordable, quality hearing aids and related services
34
Strategic Objective 4: Work with suppliers to enter L.M.I.C. markets with affordable, quality hearing aids
Strategic Objective 5: Spur innovation to support simplified provision models and introduction of optimal products
35
7. Next Steps
36
APPENDICES
APPENDIX A: INDIVIDUALS INTERVIEWED OR CONSULTED
37
38
39
APPENDIX B: PROVISION OF E.H.C. SERVICES ACROSS DIFFERENT HEALTHCARE LEVELS IN L.M.I.C.S (BASED ON EXPERT INTERVIEWS)84, 85
40
APPENDIX C: HEARING AID FITTING PROCESS
41
42
APPENDIX D: SUMMARY OF W.H.O. PREFERRED PROFILE FOR HEARING AID TECHNOLOGY SUITABLE FOR L.M.I.C.S93
43
44
Notes