Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 11
2 Introduction 14
2.1 What Is This Report About? 14
2.2 Definitions
14
2.2.1 ENT Devices 14
3 Healthcare Sector Review 16
3.1
Healthcare Expenditure 16
3.2 Healthcare Infrastructure 21
3.2.1
Healthcare Personnel Data 23
3.2.2 Healthcare Facilities Data 26
4 ENT
Devices in United States 28
4.1 ENT Devices Overall Revenues (2000-2012)
28
4.2 ENT Devices Overall Volume (2000-2012) 34
4.3 ENT Devices
Overall Company Share (2005-2006) 35
5 Hearing Aid Devices in United
States 36
5.1 Hearing Aid Devices Overall Revenues (2000-2012) 36
5.1.1 Analog Hearing Aids Overall Revenues (2000-2012) 42
5.2 Hearing Aid
Devices Overall Volume (2000-2012) 44
5.2.1 Digital Signal Processing
Hearing Aids Overall Volume (2000-2012) 46
5.2.2 Analog Hearing Aids
Overall Volume (2000-2012) 48
5.3 Hearing Aid Devices Average Price
(2000-2012) 50
5.3.1 Analog Hearing Aids Average Price (2000-2012) 50
5.3.2 Digital Signal Processing Hearing Aids Average Price (2000-2012) 52
5.4 Hearing Aid Devices Distribution Share (2005-2006) 54
5.5 Hearing Aid
Devices Company Share (2005-2006) 55
6 Hearing Implants in United States
56
6.1 Hearing Implants Overall Revenues (2000-2012) 56
6.1.1 Cochlear
Implant Overall Revenues (2000-2012) 60
6.1.2 Bone Anchored Hearing
Implants Overall Revenues (2000-2012) 62
6.2 Hearing Implants Overall
Volume (2000-2012) 64
6.2.1 Cochlear Implant Overall Volume (2000-2012)
66
6.2.2 Bone Anchored Hearing Implants Overall Volume (2000-2012) 68
6.3 Hearing Implants Average Price (2000-2012) 70
6.3.1 Bone Anchored
Hearing Implants Average Price (2000-2012) 70
6.3.2 Cochlear Implant
Average Price (2000-2012) 72
6.4 Hearing Implants Distribution Share
(2005-2006) 74
6.5 Hearing Implants Company Share (2005-2006) 75
7
Diagnostic Devices in United States 76
7.1 Diagnostic Devices Overall
Revenues (2000-2012) 76
7.1.1 Audiometer Overall Revenues (2000-2012)
80
7.1.2 Otoscope Overall Revenues (2000-2012) 82
7.2 Diagnostic
Devices Overall Volume (2000-2012) 84
7.2.1 Otoscope Overall Volume
(2000-2012) 86
7.2.2 Audiometer Overall Volume (2000-2012) 88
7.3
Diagnostic Devices Average Price (2000-2012) 90
7.3.1 Otoscope Average
Price (2000-2012) 90
7.3.2 Audiometer Average Price (2000-2012) 92
7.4
Diagnostic Devices Distribution Share (2005-2006) 94
7.5 Diagnostic
Devices Company Share (2005-2006) 95
8 William Demant Holding A/S 96
8.1.1 Company Overview 96
8.1.2 Business Overview 96
8.1.3 Value Chain
Analysis 99
8.1.4 SWOT Analysis 100
8.1.5 Financial and Operational
Review 103
8.1.6 Locations And Subsidiaries 105
9 Phonak Holding AG
107
9.1.1 Phonak Holding AG Company Overview 107
9.1.2 Phonak Holding
AG Business Overview 107
9.1.3 Value Chain Analysis 110
9.1.4 SWOT
Analysis 111
9.1.5 Financial and Operational Review 114
9.1.6
Locations And Subsidiaries 115
10 GN ReSound A/S 118
10.1.1 GN ReSound
A/S Company Overview 118
10.1.2 GN ReSound A/S Business Overview 118
10.1.3 Locations And Subsidiaries 120
11 Cochlear Limited 122
11.1.1
Cochlear Limited Company Overview 122
11.1.2 Cochlear Limited Business
Overview 122
11.1.3 Value Chain Analysis 125
11.1.4 SWOT Analysis
126
11.1.5 Financial and Operational Review 129
11.1.6 Locations And
Subsidiaries 130
12 Widex A/S 133
12.1.1 Widex A/S Company Overview
133
12.1.2 Widex A/S Business Overview 133
12.1.3 Locations And
Subsidiaries 136
13 Regulation System 137
13.1 Medical Equipment
Approval Process 137
13.1.1 Pre-market Approval Process 138
13.1.2
Intended use and Indications for use 138
13.1.3 Predicate Device 139
13.1.4 Safe and Effective 139
20.1.1 Other Category Devices 141
20.1.2
Post-Market Approval Process 142
25.1.1 Compliance and Enforcement 142
25.1.2 Registration Fee 143
25.1.3 Approval Time 143
26 Pricing and
Reimbursement 144
26.1 Government Policies 144
30.1 Private Insurance
145
38.1 Diagnosis Related Groups (DRG) 146
39 Distribution Structure
147
39.1 Distribution Structure 147
40 Financial Deals Landscape
148
40.1 Acquisition 148
40.1.1 Natus Medical Acquires SonaMed 148
40.1.2 3M Acquires Aearo Technologies From Permira 149
40.2 Private Equity
151
40.2.1 Permira Sells Aearo Technologies To 3M 151
40.3 Venture
Financing 153
40.3.1 Entellus Medical Secures $15 Million In Series C
Financing 153
40.3.2 Sinexus Secures $20 Million In Series B Financing
154
40.3.3 Zounds Secures $41 Million In Series B Financing 155
40.3.4
InSound Medical Secures $11 Million In Series E Funding 156
40.3.5
Carbylan BioSurgery Secures $20 Million In Series B Financing 157
40.3.6
Sinexus Raises $3.5 Million In Series A Funding 159
40.4 IPO 160
40.4.1 Natus Medical Completes Public Offering Of $89.7 Million 160
40.4.2
Natus Medical Completes Public Offering Of $16.18 Million 161
40.4.3
Acclarent Files For Initial Public Offering 163
41 Recent Developments
164
41.1 Strategy And Business Planning 164
41.1.1 Sep 03, 2008: Natus
Medical Plans To Acquire NeuroCom 164
41.1.2 Sep 02, 2008: Siemens Plans
$109 Million Expansion At Its Manufacturing Facility In Walpole, MA 164
41.1.3 May 06, 2008: Medtronic Announces Global Workforce Realignment 165
41.1.4 Apr 01, 2008: Texas Instruments And IIT Kharagpur To Collaborate On
Medical Technology Research 165
41.2 Research And Development 165
41.2.1 Apr 01, 2008: Texas Instruments And IIT Kharagpur To Collaborate On
Medical Technology Research 165
41.3 Corporate Communications 166
41.3.1 Aug 11, 2008: Sonic Appoints New President And COO 166
41.3.2 Jul
24, 2008: Sonic Appoints New Vice President, Auditory Research 166
41.3.3
Jul 22, 2008: AcuNetx Appoints CFO 167
41.3.4 Jul 18, 2008: Texas
Instruments Elects New Board Member 167
41.3.5 Jul 18, 2008: AcuNetx
Announces Management Changes 167
41.3.6 Jul 01, 2008: Welch Allyn Lighting
Appoints Senior Management Members 168
41.3.7 Jun 26, 2008: Medtronic
Elects New Chairman 168
41.3.8 Jun 17, 2008: America Hears Appoints New
CFO 169
41.3.9 Jun 05, 2008: Sinexus Appoints New CEO 169
41.3.10 Jun
03, 2008: AcuNetx Announces Board Changes 170
41.3.11 May 27, 2008: Welch
Allyn Appoints Senior Vice President, General Counsel 170
41.3.12 May 13,
2008: Sonic Announces Board Changes 170
41.3.13 May 05, 2008: Teleflex
Announces Board Changes 171
41.3.14 Apr 29, 2008: Medtronic Announces
Management Changes 171
41.3.15 Apr 23, 2008: Welch Allyn Appoints SVP,
EMEA And Latin America 172
41.4 Legal and Regulatory 172
41.4.1 Jul
24, 2008: ArthroCare Says SEC Starts Informal Inquiry Into Accounting
Practices After Restatement 172
41.4.2 Jul 17, 2008: FDA Settles Dispute
With Advanced Bionics Over Alleged Violations Of Federal Law 172
41.4.3
May 27, 2008: Medtronic Wins $250 Million In Patent Case Against Boston
Scientific 173
41.4.4 Apr 28, 2008: Spectranetics Settles Dispute With
Medtronic 173
41.4.5 Apr 08, 2008: Medtronic Settles Lawsuit With
Spectranetics 173
41.4.6 Apr 07, 2008: Sarraf Files Lawsuit Against
ArthroCare 174
41.5 Government and Public Interest 174
41.5.1 Sep 16,
2008: Study Examines Function Of Prosthetic Ears In Improving Hearing After
Injury 174
41.5.2 Jul 02, 2008: University Of Virginia Develops New Ear
Tube Device 175
41.5.3 Jun 26, 2008: BU Researchers Develops Prototype
Device For The Blind 175
41.5.4 Mar 28, 2008: FDA Wants To Fine $2.2
Million Against Advanced Bionics 176
42 Appendix 177
42.1 Methodology
177
42.2 Currency Conversion 178
42.3 Contact Us 179
42.4
Disclaimer 179
1.1 List of Tables
Table 1: United States
Healthcare Expenditure, 2003-2010 17
Table 2: United States Healthcare
Expenditure by Age (per person), 2000-2003 18
Table 3: United States
Healthcare Expenditure by Sex (per person), 2000-2003 18
Table 4: United
States Healthcare Expenditure by Race (per person), 2000-2003 19
Table 5:
United States Personal Healthcare Expenditure by Type, 2000-2004 19
Table
6: United States Personal Healthcare Expenditure by Source, 2000-2004 20
Table 7: Total Number of Doctors in the United States, 2003-2010 23
Table
8: Number of Doctors by Specialty in the United States, 2003-2010 24
Table
9: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 25
Table 10: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004
(Cont.) 26
Table 11: Total Hospitals in the United States, 2000-2004
26
Table 12: Community Hospitals by Number of Beds in the United States,
2000-2004 27
Table 13: Number of Hospital Beds in the United States,
2000-2004 27
Table 14: Number of Hospital Beds by Range in the United
States, 2000-2004 27
Table 15: ENT Devices, United States, Overall
Revenues ($ mn), 2000-2012 28
Table 16: ENT Devices, United States,
Overall Revenues ($ mn), Historic, 2000-2007 29
Table 17: ENT Devices,
United States, Overall Revenues ($ mn), Forecast, 2007-2012 30
Table 18:
ENT Devices, United States, Category Revenues ($ mn), 2000-2012 31
Table
19: ENT Devices, United States, Category Revenues ($ mn), Historic, 2000-2007
32
Table 20: ENT Devices, United States, Category Revenues ($ mn),
Forecast, 2007-2012 33
Table 21: ENT Devices, United States, Category
Volume (Units), 2000-2012 34
Table 22: ENT Devices, United States,
Category Volume (Units), Historic, 2000-2007 34
Table 23: ENT Devices,
United States, Category Volume (Units), Forecast, 2007-2012 34
Table 24:
ENT Devices, United States, Overall Company Share by Revenues ($ mn),
2005-2006 35
Table 25: Hearing Aid Devices, United States, Overall
Revenues ($ mn), Historic, 2000-2007 36
Table 26: Hearing Aid Devices,
United States, Overall Revenues ($ mn), Forecast, 2007-2012 37
Table 27:
Hearing Aid Devices, United States, Revenue by Segment ($ mn), Historic,
2000-2007 38
Table 28: Hearing Aid Devices, United States, Revenue by
Segment ($ mn), Forecast, 2007-2012 39
Table 29: Digital Signal Processing
Hearing Aids, United States, Overall Revenues ($ mn), Historic, 2000-2007
40
Table 30: Digital Signal Processing Hearing Aids, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 41
Table 31: Analog Hearing
Aids, United States, Overall Revenues ($ mn), Historic, 2000-2007 42
Table
32: Analog Hearing Aids, United States, Overall Revenues ($ mn), Forecast,
2007-2012 43
Table 33: Hearing Aid Devices, United States, Overall Volume
(Units), Historic, 2000-2007 44
Table 34: Hearing Aid Devices, United
States, Overall Volume (Units), Forecast, 2007-2012 45
Table 35: Digital
Signal Processing Hearing Aids, United States, Overall Volume (Units),
Historic, 2000-2007 46
Table 36: Digital Signal Processing Hearing Aids,
United States, Overall Volume (Units), Forecast, 2007-2012 47
Table 37:
Analog Hearing Aids, United States, Overall Volume (Units), Historic,
2000-2007 48
Table 38: Analog Hearing Aids, United States, Overall Volume
(Units), Forecast, 2007-2012 49
Table 39: Analog Hearing Aids, United
States, Average Price ($), Historic, 2000-2007 50
Table 40: Analog Hearing
Aids, United States, Average Price ($), Forecast, 2007-2012 51
Table 41:
Digital Signal Processing Hearing Aids, United States, Average Price ($),
Historic, 2000-2007 52
Table 42: Digital Signal Processing Hearing Aids,
United States, Average Price ($), Forecast, 2007-2012 53
Table 43: Hearing
Aid Devices, United States, Distribution Share by Revenue ($ mn), 2005-2006
54
Table 44: Hearing Implants, United States, Company Share by Revenue ,
2005-2006 55
Table 45: Hearing Implants, United States, Overall Revenues
($ mn), Historic, 2000-2007 56
Table 46: Hearing Implants, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 57
Table 47: Hearing
Implants, United States, Revenue by Segment ($ mn), Historic, 2000-2007 58
Table 48: Hearing Implants, United States, Revenue by Segment ($ mn),
Forecast, 2007-2012 59
Table 49: Cochlear implant, United States, Overall
Revenues ($ mn), Historic, 2000-2007 60
Table 50: Cochlear implant, United
States, Overall Revenues ($ mn), Forecast, 2007-2012 61
Table 51: Bone
Anchored Hearing Implants, United States, Overall Revenues ($ mn), Historic,
2000-2007 62
Table 52: Bone Anchored Hearing Implants, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 63
Table 53: Hearing
Implants, United States, Overall Volume (Units), Historic, 2000-2007 64
Table 54: Hearing Implants, United States, Overall Volume (Units), Forecast,
2007-2012 65
Table 55: Cochlear implant, United States, Overall Volume
(Units), Historic, 2000-2007 66
Table 56: Cochlear implant, United States,
Overall Volume (Units), Forecast, 2007-2012 67
Table 57: Bone Anchored
Hearing Implants, United States, Overall Volume (Units), Historic, 2000-2007
68
Table 58: Bone Anchored Hearing Implants, United States, Overall Volume
(Units), Forecast, 2007-2012 69
Table 59: Bone Anchored Hearing Implants,
United States, Average Price ($), Historic, 2000-2007 70
Table 60: Bone
Anchored Hearing Implants, United States, Average Price ($), Forecast,
2007-2012 71
Table 61: Cochlear Implant, United States, Average Price ($),
Historic, 2000-2007 72
Table 62: Cochlear Implant, United States, Average
Price ($), Forecast, 2007-2012 73
Table 63: Hearing Implants, United
States, Distribution Share by Revenue , 2005-2006 74
Table 64: Diagnostic
Devices, United States, Company Share by Revenue , 2005-2006 75
Table 65:
Diagnostic Devices, United States, Overall Revenues ($ mn), Historic,
2000-2007 76
Table 66: Diagnostic Devices, United States, Overall Revenues
($ mn), Forecast, 2007-2012 77
Table 67: Diagnostic Devices, United
States, Revenue by Segment ($ mn), Historic, 2000-2007 78
Table 68:
Diagnostic Devices, United States, Revenue by Segment ($ mn), Forecast,
2007-2012 79
Table 69: Audiometer, United States, Overall Revenues ($ mn),
Historic, 2000-2007 80
Table 70: Audiometer, United States, Overall
Revenues ($ mn), Forecast, 2007-2012 81
Table 71: Otoscope, United States,
Overall Revenues ($ mn), Historic, 2000-2007 82
Table 72: Otoscope, United
States, Overall Revenues ($ mn), Forecast, 2007-2012 83
Table 73:
Diagnostic Devices, United States, Overall Volume (Units), Historic, 2000-2007
84
Table 74: Diagnostic Devices, United States, Overall Volume (Units),
Forecast, 2007-2012 85
Table 75: Otoscope, United States, Overall Volume
(Units), Historic, 2000-2007 86
Table 76: Otoscope, United States, Overall
Volume (Units), Forecast, 2007-2012 87
Table 77: Audiometer, United
States, Overall Volume (Units), Historic, 2000-2007 88
Table 78:
Audiometer, United States, Overall Volume (Units), Forecast, 2007-2012 89
Table 79: Otoscope, United States, Average Price ($), Historic, 2000-2007
90
Table 80: Otoscope, United States, Average Price ($), Forecast,
2007-2012 91
Table 81: Audiometer, United States, Average Price ($),
Historic, 2000-2007 92
Table 82: Audiometer, United States, Average Price
($), Forecast, 2007-2012 93
Table 83: Diagnostic Devices, United States,
Distribution Share by Revenue , 2005-2006 94
Table 84: Diagnostic Devices,
United States, Company Share by Revenue , 2005-2006 95
Table 85:
William Demant Holding A/S, SWOT Analysis , 2006 100
Table 86:
William Demant Holding A/S Financial and Operational Overview, 2002-2006
103
Table 87: William Demant Holding A/S Financial and Operational
Overview, 2002-2006 (Contd.) 104
Table 88: William Demant Holding
A/S, Subsidiaries 105
Table 89: William Demant Holding A/S,
Subsidiaries(Contd.) 106
Table 90: Phonak Holding AG, SWOT Analysis ,
2007 111
Table 91: Phonak Holding AG Financial and Operational
Overview, 2003-2007 114
Table 92: Phonak Holding AG Financial and
Operational Overview, 2003-2007(Contd.) 115
Table 93: Phonak Holding
AG, Other Locations 116
Table 94: Phonak Holding AG, Other
Locations(Contd.) 117
Table 95: Phonak Holding AG, Subsidiaries
117
Table 96: GN ReSound A/S, Other Locations 120
Table 97:
GN ReSound A/S, Subsidiaries 121
Table 98: Cochlear Limited, SWOT
Analysis , 2007 126
Table 99: Cochlear Limited Financial and
Operational Overview, 2003-2007 129
Table 100: Cochlear Limited
Financial and Operational Overview, 2003-2007 130
Table 101: Cochlear
Limited, Subsidiaries 131
Table 102: Cochlear Limited,
Subsidiaries(Contd..) 132
Table 103: Widex A/S, Other Locations
136
Table 104: Medical Equipment Registration Fee in United States, 2007
143
Table 105: Medical Device Approval Time in United States, 2004 143
Table 106: Currency Conversion from USD to Local Currency at 2007 Constant
Rate 178
1.2 List of Figures
Figure 1: United States, Healthcare
Expenditure by Source, 2003 17
Figure 2: United States, Healthcare
Infrastructure, Top Level View, 2007 22
Figure 3: Healthcare Expenses
Segmentation by End User, 2003 23
Figure 4: ENT Devices, United States,
Overall Revenues ($ mn), 2000-2012 28
Figure 5: ENT Devices, United
States, Overall Revenues ($ mn), Historic, 2000-2007 29
Figure 6: ENT
Devices, United States, Overall Revenues ($ mn), Forecast, 2007-2012 30
Figure 7: ENT Devices, United States, Category Revenues ($ mn), 2000-2012
31
Figure 8: ENT Devices, United States, Category Revenues ($ mn),
Historic, 2000-2007 32
Figure 9: ENT Devices, United States, Category
Revenues ($ mn), Forecast, 2007-2012 33
Figure 10: ENT Devices, United
States, Overall Company Share (%), 2006 35
Figure 11: Hearing Aid Devices,
United States, Overall Revenues ($ mn), Historic, 2000-2007 36
Figure 12:
Hearing Aid Devices, United States, Overall Revenues ($ mn), Forecast,
2007-2012 37
Figure 13: Hearing Aid Devices, United States, Revenue by
Segment ($ mn), Historic, 2000-2007 38
Figure 14: Hearing Aid Devices,
United States, Revenue by Segment ($ mn), Forecast, 2007-2012 39
Figure
15: Digital Signal Processing Hearing Aids, United States, Overall Revenues ($
mn), Historic, 2000-2007 40
Figure 16: Digital Signal Processing Hearing
Aids, United States, Overall Revenues ($ mn), Forecast, 2007-2012 41
Figure 17: Analog Hearing Aids, United States, Overall Revenues ($ mn),
Historic, 2000-2007 42
Figure 18: Analog Hearing Aids, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 43
Figure 19: Hearing Aid
Devices, United States, Overall Volume (Units), Historic, 2000-2007 44
Figure 20: Hearing Aid Devices, United States, Overall Volume (Units),
Forecast, 2007-2012 45
Figure 21: Digital Signal Processing Hearing Aids,
United States, Overall Volume (Units), Historic, 2000-2007 46
Figure 22:
Digital Signal Processing Hearing Aids, United States, Overall Volume (Units),
Forecast, 2007-2012 47
Figure 23: Analog Hearing Aids, United States,
Overall Volume (Units), Historic, 2000-2007 48
Figure 24: Analog Hearing
Aids, United States, Overall Volume (Units), Forecast, 2007-2012 49
Figure
25: Analog Hearing Aids, United States, Average Price ($), Historic, 2000-2007
50
Figure 26: Analog Hearing Aids, United States, Average Price ($),
Forecast, 2007-2012 51
Figure 27: Digital Signal Processing Hearing Aids,
United States, Average Price ($), Historic, 2000-2007 52
Figure 28:
Digital Signal Processing Hearing Aids, United States, Average Price ($),
Forecast, 2007-2012 53
Figure 29: Hearing Aid Devices, United States,
Distribution Share (%), 2006 54
Figure 30: Hearing Implants, United
States, Company Share (%), 2006 55
Figure 31: Hearing Implants, United
States, Overall Revenues ($ mn), Historic, 2000-2007 56
Figure 32: Hearing
Implants, United States, Overall Revenues ($ mn), Forecast, 2007-2012 57
Figure 33: Hearing Implants, United States, Revenue by Segment ($ mn),
Historic, 2000-2007 58
Figure 34: Hearing Implants, United States, Revenue
by Segment ($ mn), Forecast, 2007-2012 59
Figure 35: Cochlear implant,
United States, Overall Revenues ($ mn), Historic, 2000-2007 60
Figure 36:
Cochlear implant, United States, Overall Revenues ($ mn), Forecast, 2007-2012
61
Figure 37: Bone Anchored Hearing Implants, United States, Overall
Revenues ($ mn), Historic, 2000-2007 62
Figure 38: Bone Anchored Hearing
Implants, United States, Overall Revenues ($ mn), Forecast, 2007-2012 63
Figure 39: Hearing Implants, United States, Overall Volume (Units), Historic,
2000-2007 64
Figure 40: Hearing Implants, United States, Overall Volume
(Units), Forecast, 2007-2012 65
Figure 41: Cochlear implant, United
States, Overall Volume (Units), Historic, 2000-2007 66
Figure 42: Cochlear
implant, United States, Overall Volume (Units), Forecast, 2007-2012 67
Figure 43: Bone Anchored Hearing Implants, United States, Overall Volume
(Units), Historic, 2000-2007 68
Figure 44: Bone Anchored Hearing Implants,
United States, Overall Volume (Units), Forecast, 2007-2012 69
Figure 45:
Bone Anchored Hearing Implants, United States, Average Price ($), Historic,
2000-2007 70
Figure 46: Bone Anchored Hearing Implants, United States,
Average Price ($), Forecast, 2007-2012 71
Figure 47: Cochlear Implant,
United States, Average Price ($), Historic, 2000-2007 72
Figure 48:
Cochlear Implant, United States, Average Price ($), Forecast, 2007-2012 73
Figure 49: Hearing Implants, United States, Distribution Share (%), 2006
74
Figure 50: Diagnostic Devices, United States, Company Share (%), 2006
75
Figure 51: Diagnostic Devices, United States, Overall Revenues ($ mn),
Historic, 2000-2007 76
Figure 52: Diagnostic Devices, United States,
Overall Revenues ($ mn), Forecast, 2007-2012 77
Figure 53: Diagnostic
Devices, United States, Revenue by Segment ($ mn), Historic, 2000-2007 78
Figure 54: Diagnostic Devices, United States, Revenue by Segment ($ mn),
Forecast, 2007-2012 79
Figure 55: Audiometer, United States, Overall
Revenues ($ mn), Historic, 2000-2007 80
Figure 56: Audiometer, United
States, Overall Revenues ($ mn), Forecast, 2007-2012 81
Figure 57:
Otoscope, United States, Overall Revenues ($ mn), Historic, 2000-2007 82
Figure 58: Otoscope, United States, Overall Revenues ($ mn), Forecast,
2007-2012 83
Figure 59: Diagnostic Devices, United States, Overall Volume
(Units), Historic, 2000-2007 84
Figure 60: Diagnostic Devices, United
States, Overall Volume (Units), Forecast, 2007-2012 85
Figure 61:
Otoscope, United States, Overall Volume (Units), Historic, 2000-2007 86
Figure 62: Otoscope, United States, Overall Volume (Units), Forecast,
2007-2012 87
Figure 63: Audiometer, United States, Overall Volume (Units),
Historic, 2000-2007 88
Figure 64: Audiometer, United States, Overall
Volume (Units), Forecast, 2007-2012 89
Figure 65: Otoscope, United States,
Average Price ($), Historic, 2000-2007 90
Figure 66: Otoscope, United
States, Average Price ($), Forecast, 2007-2012 91
Figure 67: Audiometer,
United States, Average Price ($), Historic, 2000-2007 92
Figure 68:
Audiometer, United States, Average Price ($), Forecast, 2007-2012 93
Figure 69: Diagnostic Devices, United States, Distribution Share (%), 2006
94
Figure 70: Diagnostic Devices, United States, Company Share (%), 2006
95
Figure 71: William Demant Holding A/S, Value Chain Analysis 99
Figure 72: Phonak Holding AG, Value Chain Analysis 110
Figure 73:
Cochlear Limited, Value Chain Analysis 125
Figure 74: Medical Equipment
Approval Process in the United States, 2007 138
Figure 75: PMA Approval
Process in the United States, 2007 140
Figure 76: The 510(k) Approval
Process for Medical Devices in the United States, 2007 141
Figure 77:
Reimbursement Structure in the United States, 2007 146
Figure 78:
Distribution Structure of Medical Equipment in the United States, 2006 147
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