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The AEA
The European Association of Hearing-Aid Professionals (AEA) represents the interest of
more than 8,000 small and medium-sized enterprises and more than 20.000 employees. It is the only European umbrella organization for
“Hearing Aid Professionals” and was founded in 1970.
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The AEA Lost in translation Lost in translation
Lost in translation Lost in translation Lost in translation
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The AEA Art. 17
In the General Assembly and in all other bodies, the debates shall be held in English
Every General Assembly is held in Brussels
Board meeting in line with European Congresses or by Videoconference
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The AEA
The aim is to improve the quality of services in hearing care, ensure a
transparent fair and competitive market and freedom of choice in the interest of
the end-user.
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A country requesting an observer membership needs to pay a symbolic fee of “one vote”. An observer member will get the following services from the AEA • They will be invited to attend the General Assembly in
Brussels with a delegation as an observer • They will be mentioned on the AEA website as a
member • They will receive the reports of AEA General Assemblies
and AEA Board Meetings • They can delegate one of their members to participate
as an observer at the ECAT meetings . The AEA observer membership can only last for 2 years
AEA member countries
2013 2015
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Regulated Profession
Regulated only in 47% of all EU countries
Regulated in 80% of all AEA member countries
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Medical Paramedical
Craftsmen- schip
Two lines of recognition & eduction
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Craftsmenship
Governors of the Wine Merchant `s Guild (1659) Petrus Christus, The Goldsmith, 1449
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Craftsmenship
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Our 3 associations have 80% of the key priorities in common
Join forces with EFHOH & EHIMA
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Hearing Awareness Week 8 – 10th of April 2013
European Hearing Awareness Week / Day
Future: Link with WHO – 3rd of March
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Hearing impaired using HI - Eu
Source EHIMA – Hearing Awareness Week European Parliament – April 2013
2007 2011
Europe: 16% 18% UK: 39% 40%
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AEA – Website
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Hearing Awareness Day at the European Parliament in Brussels on the 3rd of March 2016
Theme: The cost of untreaded
hearing loss
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Hearing Awareness Day at the European Parliament in Brussels on – 3rd of March 2016
Hosts: MEP Lidia Geringer de Oedenberg and MEP Ádám Kósa WHO hearing officer, Dr Shelly Chadha: “The International Ear Care Day” Mr Paul Breckell: “The costs of untreated hearing loss” EFHOH, Mrs Lidia Smolarek-Best: “Perspectives from people with hearing loss” AEA, Mr Mark Laureyns: “Perspectives from the European hearing aid professionals’ association” CRPD Committee, Dr László Lovászy: "About the UN Convention on the rights of persons with disabilities from a personal point of view". EU Commissioner for Health, Mr Vytenis Andriukaitis EU Commissioner for Employment, Ms MarianneThyssen
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European Standard – EN 15927
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European Standard – EN 15927
5.1 General
Assess client needs & hearing loss
Select and fit suitable hearing aids
Rehabilitation – short and long term
monitoring & support
5.2 Client contact &
registration
5.3 Hearing profile determination
Type – degree – history hearing loss
Specific needs - Medical history - Tinnitus – dizzyness – hyperacusis -
Experience with HI
5.4 Audiological assessment
Otoscopy – Pure tone audiometry – Speech audiometry – Other relevant
tests (Speech in noise – noise tolerance – reading span – localisation etc ...)
5.5 Hearing system fitting
Selection – ear impression - fine
tuning – verification – localisation – balance – client instructions for use
5.6 Follow-up services
Motivation – counseling
– auditory training – fitting follow up
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European Standard – EN 15927
Needs to include that hearing care services are mandatory in the delivery of hearing aids
Needs to focus more on hearing aid fitting <> diagnostic assessment
Needs to be more in line with current practice
More focus on transparancy and evaluation of satisfaction towared the end-user
This standard can now be opened for revision – AEA will help coordinate
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% improvement due to hearing aids 0 10 20 30 40 50 60 70
Relationships at home
Feelings about myself
Life overall
Mental health
Self-confidence
Relationships w/ children, grandchildren
Willing to participate in group activities
Sense of independence
Sense of safety
Ability to play card/board games
Social life
Physical health
Dependence on others
Relationships at work
Ability to play sports
Sex life
HI Users
Family
“National council on the ageing” study “2000” N= 2304 HI Users / 2090 Family Members
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Observed Changes Attributed to Hearing Aids (better & a lot better)
EuroTrak France 2015 (n=501 hearing aid owners ) MarkeTrak9 2014 (n=980 hearing aid owners )
28%
27%
33%
41%
41%
39%
45%
44%
55%
44%
54%
61%
31%
35%
38%
38%
45%
50%
45%
52%
44%
57%
56%
65%
0% 10% 20% 30% 40% 50% 60% 70%
Physical health
Mental ability / memory
Emotional health
Feelings about yourself
Sense of safety
Sense of independence
Confidence in yourself
Relationships at home
Relationships at work
Social life
Ability to participate in group activities
Overall ability to communicate effectively in most situations
France
US
© Anovum 2015 - EuroTrak 2015
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AEA – ECAT - Hearing Aids <> PSAP’s
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Acustika Melody – Sound Amplifier (Italy) ITE 2cc IEC 60118-7 Max Output 129,1dBSPL / Max Gain 47,9dB
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Linbest– Sound Amplifier (Austria) ITE 2cc IEC 60118-7: Max Output 125,5dBSPL / Max Gain 45,6dB
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Sokio – Hearing Aid(Germany - Greece) ITE 2cc IEC 60118-7: Max Output 126,0dBSPL / Max Gain 43,3dB
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Vitalcontrol – Sanitas (Spain/UK/Italy) ITE 2cc IEC 60118-7: Max Output 129,0dBSPL / Max Gain 42,4dB
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Mini Sound Amplifier (Greece) ITE 2cc IEC 60118-7: Max Output 134,8dBSPL / Max Gain 63,0dB
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130 dB SPL
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Example “Deutches Hörgeräte Institute” evaluation
126 dB SPL
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More “Deutches Hörgeräte Institute” evaluations
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Conclusions on the analysis of 7 Personal Amplifiers
We analysed 7 personal amplifiers The maximum output (IEC 60118-7) we measure was respectively: 129,1dBSPL, 125,5dBSPL, 126,0dBSPL, 126,0dBSPL, 129,0dBSPL, 129,0dBSPL and 134,8dBSPL … so all of them exceed this norm (Directive 2001/95/EC ) by more than 40 dB !!! Which will surely result in noise induced hearing loss when actively used. They can only be used max 2 seconds/day according to the latest WHO campaign
These products present a significant danger for public health and should be regulated as soon as possible to avoid noise induced hearing loss !
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The 7 Personal Amplifiers !
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The 7 Personal Amplifiers !
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Since these devices are promoted and presented like hearing aids – end-users don’t see the difference !
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The RAPEX System
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The European Commission Market Surveillance – Medical products
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Medical Device Directive -> Medical Device Regulation
Watch out with Annex XV! Plan A: Lobby to move “PSAP’s” in Annex XV
Annex XV (relative to Article 2(1) – number (1))
Text proposed by the Commission Amendment
The implantable or other invasive products, intended to be
used for human beings, which are listed in Annex XV shall be
considered medical devices, regardless of whether or not they
are intended by the manufacturer to be used for a medical
purpose.
ANNEX XV
LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE
DEFINITION OF ‘MEDICAL DEVICE’ REFERRED TO IN NUMBER (1) OF
ARTICLE 2(1)
1. Contact lenses;
2. Implants for modification or fixation of body parts;
3. Facial or other dermal or mucous membrane fillers;
4. Equipment for liposuction;
5. Invasive laser equipment intended to be used on the human body;
6. Intense pulsed light equipment.
The implantable or other invasive products, intended to be used for human
beings, which are listed in Annex XV shall be considered medical devices,
regardless of whether or not they are intended by the manufacturer to be
used for a medical purpose.
ANNEX XV
LIST OF PRODUCTS COVERED BY THE LAST SUBPARAGRPAH OF THE
DEFINITION OF ‘MEDICAL DEVICE’ REFERRED TO IN NUMBER (1) OF ARTICLE
2(1)
1. Contact lenses;
2. Implants for modification or fixation of body parts;
3. Facial or other dermal or mucous membrane fillers;
4. Equipment for liposuction;
5. Invasive laser equipment intended to be used on the human body;
6. Intense pulsed light equipment;
7. Personal sound amplification products that look like hearing aids but have no medical purpose as they are not intended to compensate for impaired hearing but to amplify environmental sounds for normal hearing people
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Vitalcontrol – Sanitas (Spain/UK/Italy) ITE 2cc IEC 60118-7: Max Output 129,0dBSPL / Max Gain 42,4dB
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Conclusions