Table of Contents
1 Table of Contents 2
1.1 List of Tables 10
1.2 List of Figures 12
2 Introduction 14
2.1 What Is This Report About? 14
3 Definitions of
Markets Covered in the Report 15
3.1 ENT Devices 15
3.2 Diagnostic
Devices 15
3.2.1 Audiometer 15
3.2.2 Otoscope 15
3.3 Hearing Aid
Devices 15
3.3.1 Analog Hearing Aids 15
3.3.2 Digital Signal
Processing Hearing Aids 15
3.4 Hearing Implants 15
3.4.1 Bone Anchored
Hearing Implants 15
3.4.2 Cochlear Implants 16
4 Healthcare Sector
Review 17
4.1 Healthcare Expenditure 17
4.2 Healthcare Infrastructure
21
4.2.1 Healthcare Personnel Data 22
4.2.2 Healthcare Facilities Data
26
4.3 United States Healthcare Trade Statistics 28
5 Regulation
System 29
5.1 Regulation System 29
5.2 Medical Equipment Approval
Process 29
5.2.1 Pre-market Approval Process 30
5.2.2 Intended use and
Indications for use 30
5.2.3 Predicate Device 31
5.2.4 Safe and
Effective 31
5.2.5 Other Category Devices 33
5.2.6 Post-Market
Approval Process 34
5.2.7 Compliance and Enforcement 34
5.2.8
Registration Fee 35
5.2.9 Approval Time 35
6 Pricing and Reimbursement
36
6.1 Government Policies 36
6.2 Private Insurance 37
6.3
Diagnosis Related Groups (DRG) 38
7 Distribution Structure 39
7.1
Distribution Structure 39
8 ENT Devices In United States 40
8.1 ENT
Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 40
8.2 ENT
Devices, United States, Overall Revenue ($ mn), 2000-2015 41
8.3 ENT
Devices, United States, Category Volume (Units), 2000-2015 45
8.4 ENT
Devices, United States, Company Share (2006-2007) 48
9 Diagnostic Devices
In United States 49
9.1 Diagnostic Devices Overall Revenue (2000-2015)
49
9.2 Diagnostic Devices Overall Volume (2000-2015) 51
9.3 Diagnostic
Devices Average Price (2000-2015) 53
9.4 Diagnostic Devices Distribution
Share (2007-2008) 54
9.5 Diagnostic Devices, United States, Company Share
(2006-2007) 55
10 Hearing Aid Devices In United States 56
10.1 Hearing
Aid Devices Overall Revenue (2000-2015) 56
10.2 Hearing Aid Devices
Overall Volume (2000-2015) 58
10.3 Hearing Aid Devices Average Price
(2000-2015) 60
10.4 Hearing Aid Devices Distribution Share (2007-2008)
61
10.5 Hearing Aid Devices, United States, Company Share (2006-2007)
62
11 Hearing Implants In United States 63
11.1 Hearing Implants
Overall Revenue (2000-2015) 63
11.2 Hearing Implants Overall Volume
(2000-2015) 65
11.3 Hearing Implants Average Price (2000-2015) 67
11.4
Hearing Implants Distribution Share (2007-2008) 68
11.5 Hearing Implants,
United States, Company Share (2006-2007) 69
12 Overview of Key Companies
in United States ENT Devices Market 70
12.1 William Demant Holding A/S
70
12.1.1 Company Overview 70
12.1.2 Value Chain Analysis 71
12.1.2.1 Manufacturing 71
12.1.2.2 Product Development 71
12.1.2.3
Sales and Marketing 72
12.2 Cochlear Limited 73
12.2.1 Company
Overview 73
12.2.2 Value Chain Analysis 73
12.2.2.1 Manufacturing
74
12.2.2.2 Product Development 74
12.2.2.3 Sales and Marketing 75
12.3 Sonova Holding AG 76
12.3.1 Company Overview 76
12.3.2 Value
Chain Analysis 77
12.3.2.1 Manufacturing 77
12.3.2.2 Product
Development 77
12.3.2.3 Sales and Marketing 78
12.4 Widex A/S 79
12.4.1 Company Overview 79
12.5 Siemens Healthcare 80
12.5.1 Company
Overview 80
12.5.2 Value Chain Analysis 81
12.5.2.1 Manufacturing
81
12.5.2.2 Product Development 82
12.5.2.3 Sales and Marketing 82
12.6 Sonic Innovations, Inc. 83
12.6.1 Company Overview 83
12.7 GN
ReSound A/S 83
12.7.1 Company Overview 83
12.8 Starkey Laboratories,
Inc. 83
12.8.1 Company Overview 83
12.9 Dynamic Hearing Pty Ltd 84
12.9.1 Company Overview 84
12.10 Tutogen Medical, Inc. 84
12.10.1
Company Overview 84
12.11 Welch Allyn Inc. 84
12.11.1 Company Overview
84
12.12 Miracle-Ear, Inc. 85
12.12.1 Company Overview 85
12.13
Otologics, LLC 85
12.13.1 Company Overview 85
12.13.2 Otologics, LLC
Pipeline Products 85
12.13.2.1 Otologics, LLC Pipeline Products By
Development Stage 85
12.13.2.2 Otologics, LLC Pipeline Products By Therapy
Area 85
12.14 Songbird Hearing, Inc. 86
12.14.1 Company Overview
86
12.15 Griffin Laboratories 86
12.15.1 Company Overview 86
12.16
Cybertronics, Inc. 86
12.16.1 Company Overview 86
12.17 MAICO
Diagnostics USA 86
12.17.1 Company Overview 86
12.18 Gyrus ENT, L.L.C.
87
12.18.1 Company Overview 87
12.19 InSound Medical, Inc. 87
12.19.1 Company Overview 87
12.20 aaa Medical Supply 87
12.20.1
Company Overview 87
12.21 Hocks Corp. 87
12.21.1 Company Overview
87
12.22 Entellus Medical, Inc. 88
12.22.1 Company Overview 88
12.23 Electone, Inc. 88
12.23.1 Company Overview 88
12.24 Audex, Inc.
88
12.24.1 Company Overview 88
12.25 Grace Medical, Inc. 88
12.25.1 Company Overview 88
12.26 Advanced Bionics Corporation 89
12.26.1 Company Overview 89
12.27 Advanced Cochlear Systems, Inc. 89
12.27.1 Company Overview 89
12.28 Envoy Medical Corporation 89
12.28.1
Company Overview 89
12.28.2 Envoy Medical Corporation Pipeline Products
90
12.28.2.1 Envoy Medical Corporation Pipeline Products By Equipment Type
90
12.28.2.2 Envoy Medical Corporation Pipeline Products By Development
Stage 90
12.28.2.3 Envoy Medical Corporation Pipeline Products By Therapy
Area 90
12.28.2.4 Envoy Medical Corporation Pipeline Products By Clinical
Trials 90
12.29 DeVilbiss Healthcare 91
12.29.1 Company Overview
91
12.30 Richard Wolf Medical Instruments Corporation 91
12.30.1
Company Overview 91
12.31 Sonic Innovations, Inc. 91
12.31.1 Company
Overview 91
12.32 Apherma Corporation 91
12.32.1 Company Overview
91
12.33 Zounds, Inc. 92
12.33.1 Company Overview 92
12.34 Zarman
Surgical Supply, Inc. 92
12.34.1 Company Overview 92
12.35 Siemens
Hearing Instruments, Inc. 92
12.35.1 Company Overview 92
12.36
Etymotic Research, Inc. 93
12.36.1 Company Overview 93
12.37
Acclarent, Inc. 93
12.37.1 Company Overview 93
12.38 Medical
Technologies, Inc. 93
12.38.1 Company Overview 93
12.39 Beltone 94
12.39.1 Company Overview 94
12.40 Frye Electronics, Inc 94
12.40.1
Company Overview 94
12.41 Anthony Products, Inc. 94
12.41.1 Company
Overview 94
12.42 Mountain Precision Mfg., Ltd. 94
12.42.1 Company
Overview 94
12.43 CFM Technologies, Inc. 95
12.43.1 Company Overview
95
12.44 Sinexus, Inc. 95
12.44.1 Company Overview 95
12.44.2
Sinexus, Inc. Pipeline Products 95
12.44.2.1 Sinexus, Inc. Pipeline
Products By Equipment Type 95
12.44.2.2 Sinexus, Inc. Pipeline Products By
Development Stage 95
12.44.2.3 Sinexus, Inc. Pipeline Products By Therapy
Area 95
13 Financial Deals Landscape 96
13.1 Acquisition 96
13.1.1
SETO Holdings To Acquire Advanced Hearing Centers 96
13.1.2 NovaMed
Acquires Majority Interest In Physicians Surgical Center 97
13.2
Partnerships 98
13.2.1 RTI Biologics Enters Into An Agreement With
ENTrigue Surgical 98
14 Recent Developments 99
14.1 Product News
99
14.1.1 Apr 03, 2009: Neuromonics Presents Interim Results Of
Neuromonics Tinnitus Treatment 99
14.1.2 Jan 21, 2009: Life And Motion For
Natural, Comfortable And Enhanced Hearing Experience Launched By Siemens
Hearing Instruments 100
14.1.3 Jan 09, 2009: Pulse Launches DCU Scroller
100
14.1.4 Oct 31, 2008: Siemens Introduces Life, An Open Fit Hearing
Instrument 101
14.1.5 Oct 31, 2008: Siemens Launches Motion, A Complete
Product Portfolio For Mild through Severe Hearing Loss 101
14.1.6 Oct 21,
2008: Starkey Laboratories Wins Spark Design Award For Zon 101
15 Appendix
103
15.1 Global Markets Direct Research Methodology 103
15.2 Coverage
104
15.3 Secondary Research 104
15.4 Primary Research 105
15.5
Models 105
15.6 Forecasts 106
15.7 Expert Panel Validation 106
15.8 Currency Conversion 107
15.9 Contact Us 108
15.10 Disclaimer
108
1.1 List of Tables
Table 1: United States Healthcare
Expenditure, 2000-2007 18
Table 2: United States Personal Healthcare
Expenditure by Type, 2000-2007 19
Table 3: United States Personal
Healthcare Expenditure by Source, 2000-2007 20
Table 4: Total Number of
Doctors in the United States, 2003-2010 22
Table 5: Number of Doctors by
Specialty in the United States, 2003-2010 23
Table 6: Doctors by Region
(Number per 10,000 Civilian Population), 2002-2004 24
Table 7: Doctors by
Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 25
Table
8: Total Hospitals in the United States, 2000-2004 26
Table 9: Community
Hospitals by Number of Beds in the United States, 2000-2004 26
Table 10:
Number of Hospital Beds in the United States, 2000-2004 27
Table 11:
Number of Hospital Beds by Range in the United States, 2000-2004 27
Table
12: United States Healthcare Trade Statistics, 2001-2006 28
Table 13:
Medical Equipment Registration Fee in United States, 2007 35
Table 14:
Medical Device Approval Time in United States, 2007 35
Table 15: ENT
Devices Cross Country Comparison, Revenue ($ mn), 2000-2015 40
Table 16:
ENT Devices, United States, Overall Revenue ($ mn), 2000-2015 41
Table
17: ENT Devices, United States, Cross-Category Analysis, 2000-2015 42
Table 18: ENT Devices, United States, Overall Revenue ($ mn), Historic,
2000-2008 43
Table 19: ENT Devices, United States, Overall Revenue ($
mn), Forecast, 2008-2015 44
Table 20: ENT Devices, United States,
Category Volume (Units), 2000-2015 45
Table 21: ENT Devices, United
States, Category Volume (Units), Historic, 2000-2008 46
Table 22: ENT
Devices, United States, Category Volume (Units), Forecast, 2008-2015 47
Table 23: ENT Devices, United States, Company Share by Revenue ($ mn),
2006-2007 48
Table 24: Diagnostic Devices, United States, Revenue ($
mn) by Segment, Historic, 2000-2008 49
Table 25: Diagnostic Devices,
United States, Revenue ($ mn) by Segment, Forecast, 2008-2015 50
Table 26:
Diagnostic Devices, United States, Volume (Units), Historic, 2000-2008
51
Table 27: Diagnostic Devices, United States, Volume (Units),
Forecast, 2008-2015 52
Table 28: Diagnostic Devices, United States,
Average Price ($), Historic, 2000-2008 53
Table 29: Diagnostic
Devices, United States, Average Price ($), Forecast, 2008-2015 53
Table
30: Diagnostic Devices, United States, Distribution Share by Revenue
($mn), 2007-2008 54
Table 31: Diagnostic Devices, United States,
Company Share by Revenue ($ mn), 2006-2007 55
Table 32: Hearing Aid
Devices, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 56
Table 33: Hearing Aid Devices, United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 57
Table 34: Hearing Aid Devices, United States,
Volume (Units), Historic, 2000-2008 58
Table 35: Hearing Aid Devices,
United States, Volume (Units), Forecast, 2008-2015 59
Table 36:
Hearing Aid Devices, United States, Average Price ($), Historic, 2000-2008
60
Table 37: Hearing Aid Devices, United States, Average Price ($),
Forecast, 2008-2015 60
Table 38: Hearing Aid Devices, United States,
Distribution Share by Revenue ($mn), 2007-2008 61
Table 39: Hearing
Aid Devices, United States, Company Share by Revenue ($ mn), 2006-2007 62
Table 40: Hearing Implants, United States, Revenue ($ mn) by Segment,
Historic, 2000-2008 63
Table 41: Hearing Implants, United States,
Revenue ($ mn) by Segment, Forecast, 2008-2015 64
Table 42: Hearing
Implants, United States, Volume (Units), Historic, 2000-2008 65
Table 43:
Hearing Implants, United States, Volume (Units), Forecast, 2008-2015
66
Table 44: Hearing Implants, United States, Average Price ($),
Historic, 2000-2008 67
Table 45: Hearing Implants, United States,
Average Price ($), Forecast, 2008-2015 67
Table 46: Hearing Implants,
United States, Distribution Share by Revenue ($mn), 2007-2008 68
Table 47:
Hearing Implants, United States, Company Share by Revenue ($ mn),
2006-2007 69
Table 48: Otologics, LLC Pipeline Products By
Development Stage 85
Table 49: Otologics, LLC Pipeline Products By
Therapy Area 85
Table 50: Envoy Medical Corporation Pipeline Products
by Equipment Type 90
Table 51: Envoy Medical Corporation Pipeline
Products By Development Stage 90
Table 52: Envoy Medical Corporation
Pipeline Products By Therapy Area 90
Table 53: Envoy Medical
Corporation Pipeline Products By Clinical Trials 90
Table 54:
Sinexus, Inc. Pipeline Products by Equipment Type 95
Table 55:
Sinexus, Inc. Pipeline Products By Development Stage 95
Table 56:
Sinexus, Inc. Pipeline Products By Therapy Area 95
Table 57: SETO
Holdings To Acquire Advanced Hearing Centers 96
Table 58: NovaMed
Acquires Majority Interest In Physicians Surgical Center 97
Table 59:
RTI Biologics Enters Into An Agreement With ENTrigue Surgical 98
Table 60:
USD to Local Currency, Average Exchange Rate 2008 107
1.2 List of
Figures
Figure 1: United States, Healthcare Expenditure by Source, 2007
18
Figure 2: Healthcare Expenses Segmentation by End User, 2007 19
Figure 3: United States, Healthcare Infrastructure, Top Level View, 2007
22
Figure 4: Medical Equipment Approval Process in the United States, 2007
30
Figure 5: PMA Approval Process in the United States, 2007 32
Figure 6: The 510(k) Approval Process for Medical Devices in the United
States, 2007 33
Figure 7: Reimbursement Structure in the United States,
2007 38
Figure 8: Distribution Structure of Medical Equipment in the
United States, 2007 39
Figure 9: ENT Devices Cross Country
Comparison, Revenue ($ mn), 2000-2015 40
Figure 10: ENT Devices,
United States, Overall Revenue ($ mn), 2000-2015 41
Figure 11: ENT
Devices, United States, Cross-Category Analysis, 2000-2015 42
Figure 12:
ENT Devices, United States, Overall Revenue ($ mn), Historic, 2000-2008
43
Figure 13: ENT Devices, United States, Overall Revenue ($ mn),
Forecast, 2008-2015 44
Figure 14: ENT Devices, United States,
Category Volume (Units), 2000-2015 45
Figure 15: ENT Devices, United
States, Category Volume (Units), Historic, 2000-2008 46
Figure 16:
ENT Devices, United States, Category Volume (Units), Forecast, 2008-2015
47
Figure 17: ENT Devices, United States, Company Share (%), 2007
48
Figure 18: Diagnostic Devices, United States, Revenue ($ mn) by
Segment, Historic, 2000-2008 49
Figure 19: Diagnostic Devices, United
States, Revenue ($ mn) by Segment, Forecast, 2008-2015 50
Figure 20:
Diagnostic Devices, United States, Volume (Units), Historic, 2000-2008 51
Figure 21: Diagnostic Devices, United States, Volume (Units), Forecast,
2008-2015 52
Figure 22: Diagnostic Devices, United States, Company
Share (%), 2007 55
Figure 23: Hearing Aid Devices, United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 56
Figure 24: Hearing
Aid Devices, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015
57
Figure 25: Hearing Aid Devices, United States, Volume (Units),
Historic, 2000-2008 58
Figure 26: Hearing Aid Devices, United States,
Volume (Units), Forecast, 2008-2015 59
Figure 27: Hearing Aid
Devices, United States, Company Share (%), 2007 62
Figure 28: Hearing
Implants, United States, Revenue ($ mn) by Segment, Historic, 2000-2008 63
Figure 29: Hearing Implants, United States, Revenue ($ mn) by Segment,
Forecast, 2008-2015 64
Figure 30: Hearing Implants, United States,
Volume (Units), Historic, 2000-2008 65
Figure 31: Hearing Implants,
United States, Volume (Units), Forecast, 2008-2015 66
Figure 32:
Hearing Implants, United States, Company Share (%), 2007 69
Figure 33:
William Demant Holding A/S Value Chain Analysis 71
Figure 34:
Cochlear Limited Value Chain Analysis 73
Figure 35: Phonak Holding AG
Value Chain Analysis 77
Figure 36: Siemens Medical Solutions Value
Chain Analysis 81
Figure 37: Global Markets Direct Methodology 103
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