1. Amsterdam, April 14, 2015 EHIMA MDC Report to the Board

2. Agenda Hear-it update & Social Media and Hear-it.org Common stance overall topics –Common stance PSAPs European awareness campaign EuroTrak 2015 2

3. New funnel strategy New focused Persona centric content development Increase traffic (SEO, Social Media) Visitor journey analytics (per persona) Analytic based ongoing fine-tuning

4. Audience / Targetgroups InformationVisitsInformationVisitsInformationVisitsInformation Funnel strategy KPIs Traffic Visits to pages in hear-it sections about hearing and hearing loss Visits to specific pages (KPI conversion targets) 4 Attention Interest Desire

5. Aggregated conversion rates Q1 2015 5

6. Total - visitors

7. Social Media and Hear-it.org Update

8. Social Media Vision Hear-it.org social media activities lead to an increase in traffic to the hear-it website and a higher level of engagement with our audience Expose - Engage - Lead - Motivate 8

9. Strategic goals Increase exposure of hear-it.org on social media Engage users more Motivate the hearing impaired to do something about their hearing Motivate significant others Lead more people from social media channels to hear-it.org 9

10. Operational goals More followers on Facebook Open YouTube channel More user engagement and sharing More visits to Hear-it.org We find and give the best answers within 24 hours Key KPIs to be defined 10

11. Target Groups People with hearing loss People who believe they have a hearing loss People with tinnitus Significant others 50+ English speaking/reading (primary or secondary language) 11

12. Main Platforms Facebook is the fastest growing platform within our target group and we will focus mainly on communicating here. Video is the content of choice. YouTube together with Facebook are the two most important platforms to deploy video. 12

13. Budget situation - reminder 2015 budget approved at EHIMA Board meeting in October 2014. –Hear-it website activities: 540K –Social media activities 60K 13

14. Hear-It Social Media – Budget breakdown Strategy consulting € 7,000 Planning, content creation, production, monitoring and publishing Facebook€ 20,000 YouTube€ 14,000 Other channels (Google+, Twitter)€ 4,000 Marketing, paid-media€ 10.000 Monitoring, research, measuring, administration € 5.000 Total€ 60,000

15. Common Stance: Proposal for topics

16. Common stance topics - proposal EHIMA supports the UN Declaration on the Rights of People with Disabilities EHIMA strives to cooperate with both professional and user organizations EHIMA fundamentally believes that hearing aids are Medical Devices, for the benefit and safety of the hearing impaired EHIMA supports professional counseling and fitting of hearing aids by qualified professionals. Including a mandatory continuing education system (e.g. USA ) EHIMA supports the introduction of adult hearing screening programs to ensure early intervention and maintain cognitive capacities EHIMA supports universal hearing screening of newborns EHIMA strives to ensure interference-free access to standardized wireless communication Discussion, Decision?

17. Common Stance: PSAPs

18. USA – FDA guidance February 2009 –Outlining the differences between Hearing Aids and PSAP:s –Key principle is ”intended use” written in labeling November 2013 –FDA circulated an updated guidance document for comments –A key change in the proposal - if a PSAP ”behaves” as a Hearing Aid it is defined as a hearing aid -> medical device 3/24/2015 L.Hagander

19. EU regulations –Medical Device Directive issued 2008 states that labelling material (Instructions for use) outlines the medical purpose of a device. This defines if it is an audio apparatus (PSAP) or not. –If no medical purpose is defined in PSAP instructions for use, a number of audio/video standards come into force defining that max output is key. –Product has to be CE marked according to those harmonized standards telling -> less than 100dB max SPL and 90 Laeq and a warning has to be written in the instructions for use 3/24/2015 L.Hagander

20. Challenge and conclusion FDA 2013 new guidance document ”tightens up” requirements for PSAP. Document is still under commenting and HIA is closely monitoring to ensure that guidelines are not ”softened up” The FDA want to enforce the definitionns in 2013 version. FDA will not ”open door” for PSAPs, unless Congress will enforce that Once released by FDA it is expected that FDA inspectors will enforce EU, it is very unlikely that any change will come in regulatory documents for Hearing aids and Audio apparatus/PSAP. EU system does not go into such detail Consistent enforcement in all EU countries is difficult since Notified Body System is National and accredited by Competent Authority HA manufacturers will have to monitor each market and report to their CA 20 3/24/2015 L.Hagander

21. APPENDIX For documentation – not presentation 21 3/24/2015 L.Hagander

22. US status - FDA guidance Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products –Draft Guidance for Industry and Food and Drug Administration Staff –Document issued on: November 7, 2013 for comments and will supersede February 2009 edition. –Identifies applicable legal requirements under the Food, Drug, and Cosmetic Act (the Act) for hearing aids and for personal sound amplification products (PSAPs ). 22 3/24/2015 L.Hagander

23. FDA Definitions Hearing Aid –A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.” (21 CFR 801.420) PSAP –PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. They are intended to accentuate sounds in specific listening environments, rather than for everyday use in multiple listening situations. They are not intended to compensate for hearing impairment or to address listening situations that are typically associated with and indicative of hearing loss (Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures….) 23 3/24/2015 L.Hagander

24. How to distinguish ? FDA Labeling The intended use of each article determines whether it is a (medical) device or an electronic product. Technology and function of hearing aids and PSAPs may be similar, The intended use may be established by labeling materials. Promotional materials that make claims or suggest the use of a PSAP for hearing impaired consumers, such as in the description of the types and severity of hearing loss, establish an intended use that causes the product to be a (medical) device therefore subject to the regulatory requirements for a hearing aid device Examples of such labeling claims and language that would establish an intended use as a medical device include: –a description of the types and severity of hearing loss –description of listening situations that are typically associated with and indicative of hearing loss –wording to suggest that the product is an alternative to a hearing aid. 24 3/24/2015 L.Hagander

25. US Requirements for Hearing Aids and PSAP Hearing Aids –Regulatory definition of a class I hearing aid is codified in 21 CFR 874.3300 Hearing Aid and 874.3305 Wireless hearing Aid –FDA Recognized standards: ANSI S 3.22:2009, ANSI C63.19-2011,EN10993 –All hearing aids must comply with specific requirements regarding patient and professional labeling identified in 21 CFR 801.420. -> 132 dB Warning –Hearing aids must comply with the required conditions for sale, as stated in 21 CFR 801.421. A -> Statement from licensed Physiciest, Keep records 3yr PSAP –PSAPs are subject to applicable provisions of the Radiation Control for Health and Safety Act of 1968, under which FDA regulates electronic products that emit sonic vibrations, such as sound amplification equipment. (See also 21 CFR 1000.15) No standard applicable. General Radiological Health requirements apply. [1000-1005] (not a lot of content) 25 3/24/2015 L.Hagander

26. EU status, Definitions Definition of Medical Device acc. to 93/42/MDD ”.. ‘medical device’ means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: –diagnosis, prevention, monitoring, treatment or alleviation of disease, –diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,….” MEDDEV 2.1 /1 1994 -> Medical purpose “Medical devices are defined as articles which are intended to be used for a medical purpose. The medical purpose is assigned to a product by the manufacturer. The manufacturer determines through the label, the instruction for use and the promotional material related to a given device its specific medical purpose.” 26 3/24/2015 L.Hagander

27. EU Requirements Hearing Aids Harmonized standards -> product standards used to CE-mark –IEC/EN 60 118-0,-7 (E-acoust), IEC/EN 60118-13 (EMC) –EN 10993 Biocompatibility –ISO/EN 60601-1 Basic Safety, Coming up IEC 60601-2-66 PSAP –PSAP does not exist as an expression in EU -> Audio apparatus –CE marking required acc to harmonized standards –EN 60065:2002 Audio, video and similar electronic apparatus. Safety requirements –EN 60950-2006 / A12 – Standard for Inform. Technology Equipment and personal music player –EN 50332-1:2000 Maximum sound pressure level methodolology and limit considerations, Portable Soundsystem equipment -> less than 100dB max SPL and 90 LAeq Laeq, T<= 85dBA, Acoustics output never to exceed 100dBA Add warning “do not listen to high Volume during longer periods…” 27 3/24/2015 L.Hagander

28. PSAP common stance next steps Does the board agree? Course of action? 28

29. MDC suggested enforcement options – Three possible activity levels Light - Urge enforcement based on existing standards and guidelines Pushy – Drive for standards and guidelines to be transformed into legislation or similar enforceable regulations. Aggressive - Couple the above with aggressive PR possibly together with users’ organizations. Theme: user safety National manufacturers organizations could analyze the 3 levels and implement activities in each country 29

30. European Awareness campaign

31. Hearing Awareness Week EU Parliament WHO International Ear Care Day 3.3.2015 Awareness campaign to European dispensers (with AEA) Original idea: Awareness project 31

32. Awareness campaign to dispensers The idea –Create awareness on the importance of hearing check The goal –Getting people into the system earlier The message –Eyes checked! Teeth checked! Ears checked? –(winning idea from the Ida Institute ) 32

42. Awareness campaign results Picked up by 12 countries Available in 15 language versions Promoted in multiple channels – on and offline Appreciated by professional organization Campaign can be reused over the next few years Very low cost - € 7,000 42

43. EuroTrak 2015 Key results overview

44. The EuroTrak Research Series Page 44 Country200920122015 Germany France UK Switzerland ItalyIn progress JapanIn progress Norway2016? Denmark2016?

45. EuroTrak Topics Overview 2009 Baseline data: Prevalence/Adoption Satisfaction with HA Reasons not to use HA Positive Impact of HA Comparison with US- MarkeTrak 2012 Trends compared to baseline data New in 2012: Reasons for drop-outs Potential social cost- savings Miscellaneous Comparison with new countries 2015 Trends compared to 2009/2012 Prevalence/Adoption Satisfaction with HA Reasons not to use HA Positive Impact of HA NEW in 2015 Where is hearing tested Sources of information Awareness of HL before HA Use of Accessories/Telecoil Importance of listening situations Quality of life/sleep Image of HA = uncomfortable? Social rejection of HA vs. bad hearing Page 45© Anovum 2015 - EuroTrak 2015

46. Key points: Basic data TopicInsights Market overview Prevalence remains stable HA Adoption remains stable HA non-owners still don’t know about third party pay Potential social cost-savings HA owners have a lower risk of being depressed HA owners feel less exhausted in the evenings Satisfaction with hearing aids The French and the Swiss are still the most satisfied In the UK, the “% in the drawer” is highest The most important influencing factors In France, price is still more important than in the UK or Germany Price is much more important for non-owners Page 46

47. Prevalence for stated hearing loss remains stable - with Germany highest Page 47 9.7% 12.1%*9.3% Stated hearing loss prevalence 2015 *Germany has the oldest population.

48. HA adoption & binaural rate slowly increasing Page 48 Binaural: 54% -> 61%66% -> 75%66% -> 70%

49. Hearing aids are useful on the job. Page 49

50. HA owners have a lower risk of being depressed Depression symptoms: Dementia symptom: Base: hearing aid n=402 / no hearing aid =118 Page 50 Similar for Germany and France

51. HA owners feel less exhausted in the evenings Base : Top 50% n=134 / hearing aid n=367 In the evenings I often feel physically exhausted In the evenings I often feel mentally exhausted Page 51 Similar for UK and France

52. Key points: The new topics (1) TopicInsights The route to the hearing aid In the UK, the NHS and family doctors do most hearing tests, in Germany and France it is the ENT Online/smartphone hearing tests are not (yet) relevant Doctors and HA Professionals are the most important sources of information – followed by other people with hearing aids On average 2-3 years pass between becoming aware of the hearing loss and the purchase of hearing aids Brand awareness and -loyalty Awareness of one’s hearing aid brand varies strongly across the countries Less than 50% are loyal to the currently owned brand Accessories and Telecoil Usage of hearing aid accessories is very low in all countries Awareness and usage of Telecoil is much higher in the UK. Only a few use Telecoil. Those who use it, tend to like it. Page 52

53. Key points: The new topics (2) TopicInsights Some nice new “PR-stories” A huge majority say their HAs work better than or as expected Quality of sleep seems to improve if hearing impaired use HAs 92% to 98% declare that their HAs improve their quality of life 89% HA owners think people don’t make fun of them because of their hearing aids More people make fun of hearing impaired non-users (35%) Page 53

54. Awareness of hearing aid brand varies strongly Less than 50% are loyal to the currently owned brand Page 54 Are you aware of the brand of your hearing aid(s)? (N=605) (N=505) (N=501) (N=619) In case you plan to obtain new hearing aid(s), what brand would you choose? (N=605) (N=505) (N=501) (N=619)

55. Usage of HA accessories is very low in all countries Which of the following accessories have you heard of and which ones do you own? Base: N=505 Page 55 Similar in UK/France

56. Quality of sleep seems to improve if hearing impaired use hearing aids. Are you generally satisfied with the quality of your sleep? Page 56 similar for Germany/France

57. Vast majority declare that their hearing aids improve their quality of life How often do your hearing aids improve your quality of life? Page 57 Base: N=605 Base: N=505 Base: N=501

58. 89% think people don’t make fun of them because of their HAs. More people make fun of hearing impaired non-users. Hearing aid owners: How often do you feel you are made fun of or rejected because you are wearing a hearing aid? Base: N=505 Hearing impaired non-owners: How often do you feel you are made fun of or rejected because of your hearing loss? Base: Top 50% hearing loss, no hearing aid N=209 Page 58 similar in UK/France

59. EuroTrak 15 Conclusions Basic data from 2009 + 2012 are confirmed Some trends detected New insights gained from new questions/new topics Improved collaboration with stakeholders Next steps –Coordination with associations in individual countries –Incorporate results from Italy and Japan –Plan communication, together with HIA / MarkeTrak –Start the PR machine going: Le Monde already mentioned EuroTrak 2015 Page 59