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.

The AEA Lost in translation Lost in translation

Lost in translation Lost in translation Lost in translation

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

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.

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

Regulated Profession

Regulated only in 47% of all EU countries

Regulated in 80% of all AEA member countries

Medical Paramedical

Craftsmen- schip

Two lines of recognition & eduction

Craftsmenship

Governors of the Wine Merchant `s Guild (1659) Petrus Christus, The Goldsmith, 1449

Craftsmenship

Our 3 associations have 80% of the key priorities in common

Join forces with EFHOH & EHIMA

Hearing Awareness Week 8 – 10th of April 2013

European Hearing Awareness Week / Day

Future: Link with WHO – 3rd of March

Hearing impaired using HI - Eu

Source EHIMA – Hearing Awareness Week European Parliament – April 2013

2007 2011

Europe: 16% 18% UK: 39% 40%

AEA – Website

Hearing Awareness Day at the European Parliament in Brussels on the 3rd of March 2016

Theme: The cost of untreaded

hearing loss

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

European Standard – EN 15927

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

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

% 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

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

AEA – ECAT - Hearing Aids <> PSAP’s

Acustika Melody – Sound Amplifier (Italy) ITE 2cc IEC 60118-7 Max Output 129,1dBSPL / Max Gain 47,9dB

Linbest– Sound Amplifier (Austria) ITE 2cc IEC 60118-7: Max Output 125,5dBSPL / Max Gain 45,6dB

Sokio – Hearing Aid(Germany - Greece) ITE 2cc IEC 60118-7: Max Output 126,0dBSPL / Max Gain 43,3dB

Vitalcontrol – Sanitas (Spain/UK/Italy) ITE 2cc IEC 60118-7: Max Output 129,0dBSPL / Max Gain 42,4dB

Mini Sound Amplifier (Greece) ITE 2cc IEC 60118-7: Max Output 134,8dBSPL / Max Gain 63,0dB

130 dB SPL

Example “Deutches Hörgeräte Institute” evaluation

126 dB SPL

More “Deutches Hörgeräte Institute” evaluations

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 !

The 7 Personal Amplifiers !

The 7 Personal Amplifiers !

Since these devices are promoted and presented like hearing aids – end-users don’t see the difference !

The RAPEX System

The European Commission Market Surveillance – Medical products

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

Vitalcontrol – Sanitas (Spain/UK/Italy) ITE 2cc IEC 60118-7: Max Output 129,0dBSPL / Max Gain 42,4dB

Conclusions