CEN 380/NS-EN 15927 Standard for

Services Offered by Hearing Aid Professionals(og litt om ”Oppfølging av samarbeidsavtale om formidling av høreapparat og

høretekniske hjelpemidler”.)

NTAF 12.11.10Georg Træland

Sørlandet Sykehus HF

BTT200

Land representert

Belgia Danmark

Finland Frankrike

Irland Italia

Nederland Norge

Spania Sveits

Sverige Tyskland

Østerrike

ANEC (Europeisk brukerorganisasjon for hørselshemmede )

Hva NS-EN 15927 er

“This European Standard provides a set of minimum requirements for the essential elements of the service provision. Furthermore, recommendations for other aspects of good practice are provided. “

“Emphasis is placed on defining requirements for the elements of the service provision where the quality of the service offered is not readily assessed by the average client. “

Hva NS-EN 15927 ikke er-

“Certain groups of hearing impaired such as children, persons with other disabilities or persons with implantable devices may require services beyond what is covered in this European Standard. “

Kjerneområder

1) educational requirements specifying the competencies that shall be required to perform the services;

2) facility requirements specifying how the appropriate environment shall be for the proper delivery of the services;

3) equipment requirements specifying what the necessary equipment for performing the services shall be;

4) ethical recommendations specifying what the ethical framework and code of conduct should be.

Educational requirements

In order to be in compliance with this European Standard the hearing aid professional shall hold qualifications recognised by applicable national laws and regulations concerning hearing aid services. The qualifications should correspond to point (d) of article 11 in Directive 2005/36/EC. However, as a minimum the qualifications shall correspond to a degree of Article 11 point (c) of this directive.

Facilities

• The service units where hearing aid professionals deliver their services ……the facilities of the practice unit shall meet standards that ensure proper performance of the services

• .. may include trainees from educational programs in their staff. Services performed by trainees shall take place under the supervision of the hearing aid professional that shall be present at the premises and who remains responsible for the activities.

Facilities

• ……the following service areas shall be available:

⎯ reception area;

⎯ counselling area;

⎯ audiometry area;

⎯ fitting area;

⎯ maintenance area.

• …. different types of equipment are needed for proper performance of the service processes…– Audiometric equipment

– Otoscopy and ear-mould

– Hearing aid programming

– Electro-acoustic measurement equipment

– Maintenance tools

– Demonstration tools

• Audiometry area – Hearing threshold levels.. down to 20 dB HL for air conduction

( EN ISO 8253-1,2,3)

• 4.3.5 Fitting area

⎯ a minimum surface area of 10 m2 and a minimum volume of 25 m3;

⎯ reverberation time should be less than 0,5 s at 500 Hz;

⎯ an equivalent A-weighted ambient sound pressure level of less than 40 dB under operating conditions;

⎯ no dominant pure-tone components in the background noise.

Audiometry

• ….an audiometer shall be used for testing of air-conduction as well as bone-conduction using masking when applicable. should be capable of measuring with earphones as well as insert phones.

• The audiometer shall be a pure-tone audiometer type 1 or type 2 fulfilling the requirements of EN 60645-1. The performance of this equipment shall be checked and calibrated according to EN ISO 8253-1 and the relevant parts of EN ISO 389.

• For speech audiometry, equipment fulfilling the requirements of EN 60645-2 shall be available. Power amplifier and loudspeaker shall be available if sound field speech audiometry is performed. The performance of this equipment shall be checked and calibrated according to EN ISO 8253-3.

• The maximum interval between objective periodical checks of the audiometric equipment shall not exceed 12 months. If national legislation calls for more frequent checks these shall be applied.

Electro-Acoustic Measurements

• Electro-acoustic measurement equipment Electro-acoustic equipment for measuring hearing aid characteristics on acoustic coupler or ear simulator in accordance with EN 60118-7 shall be available.

Furthermore, the following equipment should also be available:

–equipment for the measurement of real-ear acoustical characteristics of hearing aids (EN 61669)

– a class 1 or class 2 sound level meter according to EN 61672-1.

–The maximum interval between calibrations of such electro-acoustic equipment shall not exceed 12 months.

Hearing aid provision process 1. Client contact and registration

2. Hearing profile determination– The following conditions shall be considered for the hearing profile and properly

documented:

1. type, degree and history of the hearing impairment;

2. communication and hearing disabilities, social consequences;

3. relevant living conditions, and the need for assistive listening

4. devices, hearing expectations and individual hearing situations;

5. relevant medical history including allergies and medication

6. fine motor skill impairments, visual impairments or other disabilities

7. tinnitus, dizziness and hyperacusis

8. previous use of hearing aid and other assistive devices.

Hearing aid provision process 3. Audiological assessment

1. Otoscopy

2. Pure-tone audiometry shall be carried out (EN ISO 8253-1.) Hearing thresholds (with masking if necessary) shall be determined at least at the following frequencies: - air conduction: 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz, 6000 Hz and 8000 Hz; - bone conduction: 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

3. Speech audiometry shall always be considered. 1. Speech audiometry as in EN ISO 8253-3. Speech test material as specified

in EN ISO 8253-3 shall be used, if available. The speech signal may be presented monaurally through earphones or binaurally in a sound field.

2. Speech presented in a background of competing noise should be used since it represents a more realistic situation than speech in quiet.

Hearing aid provision process 4. If deemed relevant other audiometric tests shall be carried out. Such

measurements could be:• tympanometry, a tympanometer fulfilling the requirements in EN 60645-

5 shall be used; • loudness discomfort level (UCL) at relevant frequencies; • most comfortable loudness (MCL) at relevant frequencies; • loudness scaling at relevant frequencies, the procedure shall follow ISO

16832.

5. Medical referral • If the results of the audiological assessment and the hearing profile

indicate a disease or other cause of the hearing loss that could need medical or surgical treatment, the hearing aid professional shall refer the client to a medical specialist.

Hearing aid provision process 4. Hearing system fitting

1. Choice of hearing system components

2. Preparations for fine-tuning

3. Fine-tuning of hearing aids

4. Verification of fitting

5. Client instructions

6. Follow-up services

5. Maintenance

1. Choice of hearing system components:The various options in terms of models, styles, feature levels including induction

pick-up coil, accessories and prices shall be presented to the client and their respective advantages and limitations described.

If no contra-indications are present, bilateral fitting shall be recommended.

The choice of hearing system(s) to be fitted as well as other assistive listening devices shall be based on informed consent by the client with all relevant information including the financial implications. Product and cost documentation on the proposed solution shall be given to the client.

Hearing aid provision process

2. Preparations for fine-tuningThe hearing aid professional shall enter the following data in the fitting system from the manufacturer:

⎯ data from the audiological assessment;

⎯ data from the hearing profile;

⎯ properties of acoustic coupling (e.g. ear-mould).

Based on this data, a pre-setting shall be programmed into the hearing aid to be the starting point for the fine-tuning of the fitting.

Hearing aid provision process

3. Fine-tuning of hearing aids – ..verify the proper physical fit. If the fit is not accepted the custom

ear-mould/shell shall be modified until proper fit is achieved.

– The hearing aid is fine-tuned in close interaction with the client until a setting, accepted by the client, has been reached.

– In cases where an acceptable fitting is not easily obtained, additional surveys shall be carried out to identify the ways to improve the fitting. If real-ear measurements are performed they shall follow ISO 12124.

– … the fine-tuning procedure shall be repeated for all programs, considering the specific listening situations for which they are intended to be used.

Hearing aid provision process

4. Verification of fittingTo verify that a proper fitting has been achieved, to test for improvement in hearing ability.

It shall be assured that no discomfort is created in particularly loud situations. The client shall be exposed to situations that likely will be part of the client’s everyday life in accordance with the hearing profile.

Verification of improvement in hearing ability should be assessed in multiple ways. At least one of these shall be used and the results reviewed with the client:

Hearing aid provision process

Hearing aid provision process

- speech audiometry in sound field with and without noise, aided compared to unaided, following the procedure specified in EN ISO 8253-3;

⎯ surveys with real-ear measurements to verify that the response achieved matches the proposed fitting target, following the procedure specified in ISO 12124. Client preferences may result in deviations from the proposed target;

⎯ questionnaire concerning the perceived benefit of the hearing system. The questions may refer to before and after fitting or focus directly on perceived benefit. A scientifically validated questionnaire should be used, and the client should have at least several weeks of everyday experience with the hearing system;

Hearing aid provision process

• other verification methods that can also be applied are:

– measurement of aided hearing threshold levels in sound field according to EN ISO 8253-2;

– localisation performance using loudspeaker arrays.

– presentation of relevant soundscapes

5. Verification of fitting

Before the fitting process can be considered completed the client shall be given a comprehensive introduction to the hearing systems fitted and available assistive listening devices, in particular to clients who have no previous experience of using a hearing aid. This shall at least include:

– product-specific instructions and demonstrations;

– instructions and demonstrations on how to place and operate the hearing aids;

– instructions and demonstrations on how to replace batteries;

– hearing tactics: teaching and training of individual behavioural patterns to cope with difficult acoustic environments;

– advise on the use of the hearing aid with induction loops or other hearing enhancement systems within buildings;

– instructions on how to clean and maintain hearing aids and ear-moulds.

Hearing aid provision process

6. Fitting follow-up A first follow-up appointment shall be scheduled shortly after fitting verification.

This appointment is to check the hearing system fitting after the client has completed a period of adaptation in the client’s everyday environment.

Conditions that shall be considered are:

⎯ state of outer ear by otoscopy;

⎯ physical appearance and fit;

⎯ operational issues in use of the hearing system;

⎯ cerumen problems;

⎯ auditory performance.

If needed, further adjustments of the hearing aid settings shall be performed to improve hearing system performance. Additional follow-up appointments shall be suggested to the client.

At each follow-up appointment the statements by the client and the solutions provided shall be added to the client record.

Hearing aid provision process

Quality management system • The services offered by hearing aid professionals shall be

covered by a quality management system

• Documentation The hearing aid professional shall maintain a client file system where all activities and interactions with clients are

recorded. More specifically the record shall include at least the following elements:

⎯ client demographic information;

⎯ client medical affiliations;

⎯ client hearing profile;

⎯ hearing system type and serial number for traceability according to Directive 93/42/EEC T;

⎯ fitting appointments;

⎯ fitting settings;

⎯ fitting verification;

⎯ follow-up adjustments;

⎯ report to prescribing physician, if applicable.

The file system can be either paper or computer based.

Quality management system

• 6.3 Customer complaint handling

• 6.4 Client evaluation of services

• 6.5 Corrective actions

Status

• Resultater av avstemming:– 24 stemte for– 5 unnlot å stemme (Malta, Cyprus, Croatia,Estonia & Portugal)– Ingen imot

Time ScheduleCEN 380 Services Offered by Hearing Aid Professionals

Oppfølging av samarbeidsavtale om formidling av høreapparat og

høretekniske hjelpemidler.

1.Utarbeide forslag til rutiner for rekvisisjon og refusjon av høreapparater som ivaretar partenes behov, samtidig som det gir NAV økonomikontroll. Forslaget skal også ivareta håndtering av brukers eventuelle egenandel. 2.Utarbeide forslag til løsninger/modeller/rutiner for utprøvingslager ved hørselssentraler og avtalespesialister, som sikrer brukerne gode og likeverdige muligheter for utprøving av apparater og som sikrer god økonomikontroll for NAV som betaler. Herunder skal det defineres krav til hva som er et tilstrekkelig og hensiktsmessig utprøvingslager på hørselssentralen og hos avtalespesialisten. 3.Utarbeide forslag til løsninger/rutiner for reparasjon og service som sikrer kvalitet og økonomikontroll. 4.Identifisere partenes behov for nødvendig informasjon og utarbeide forslag til system/modell og rutiner for registrering av høreapparat, som innenfor dagens muligheter tilfredsstiller partenes behov for informasjon og som bidrar til et enhetlig system for lager og logistikk

Mandat

Løsningsforslag Rutiner

• En koordinerende områdehørselssentral

Rutinerrekvisisjon

• Søknad sendes NAV etter at høreapparatformidler har levert ut apparat til varig bruk. Søknadsprosess gjøres lik for hørselssentraler og avtalespesialister.

• Utarbeide nytt søknadsskjema forhåpentligvis med krav om objektiv evaluering av nytte…

Løsningsforslagutprøvingslager

• 1. alternativ: Leverandøren har ansvaret for utprøvingslageret

• 2. alternativ: NAV har ansvaret for lageret

• 3. alternativ: Spesialisttjenesten har ansvaret

Løsningsforslagreparasjon og service

• Hovedregelen  er at bruker sender høreapparat til hørselssentral for uavhengig kontroll.

•  Hørselssentralen vurderer/kontrollerer på vegne av  NAV behovet for reparasjon.

• Alle reparasjonsfakturaer sendes via hørselssentral for kontroll.

• Reparasjonsrekvisisjon?