SIST EN 61669:2016/A1:2025

Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids (IEC 61669:2015/AMD1:2025)

Elektroakustik - Messung der Kenndaten von Hörgeräten am menschlichen Ohr (IEC 61669:2015/AMD1:2025)

Électroacoustique - Mesure des caractéristiques de performances acoustiques des appareils de correction auditive sur une oreille réelle (IEC 61669:2015/AMD1:2025)

Elektroakustika - Meritve akustičnih karakteristik slušnih pripomočkov v človeškem ušesu - Dopolnilo A1 (IEC 61669:2015/AMD1:2025)

General Information

• Status: Published
• Public Enquiry End Date: 30-Sep-2024
• Publication Date: 05-Mar-2025
• ICS: 11.180.15 - Aids for deaf and hearing impaired people
• ICS: 17.140.50 - Electroacoustics
• Technical Committee: I11 - Imaginarni 11
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 05-Mar-2025
• Due Date: 10-May-2025
• Completion Date: 06-Mar-2025
• Ref Project: EN 61669:2016/A1:2025 - Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids

Relations

• Amends: SIST EN 61669:2016 - Electroacoustics - Measurement of real-ear acoustical performance characteristics of hearing aids
• Effective Date: 01-Apr-2025

Overview

SIST EN 61669:2016/A1:2025 is a European harmonized standard under the umbrella of electroacoustics, specifically focused on the measurement of real-ear acoustical performance characteristics of hearing aids. This amendment (A1) updates the original EN 61669:2016 standard in alignment with IEC 61669:2015/AMD1:2025, ensuring precision and consistency in evaluating hearing aids' acoustic output as experienced by the user in real-ear conditions.

The standard is maintained by the European Committee for Electrotechnical Standardization (CENELEC) and reflects international cooperation via the International Electrotechnical Commission (IEC). It serves as a critical reference for manufacturers, developers, and audiologists working within hearing aid design, testing, and quality control.

Key Topics

• Real-Ear Measurement Techniques
  The standard establishes methodologies for assessing hearing aids' acoustic performance inside the human ear canal, capturing real-world sound delivery rather than laboratory simulations.

• Acoustical Performance Characteristics
  Key parameters include sound pressure levels (SPL), frequency response, and gain as they occur in the user's ear. The amendment updates calculation methods with revised equations improving accuracy.

• Calibration and Correction Factors
  SIST EN 61669:2016/A1:2025 details corrections for different earphone types and earmoulds used during audiometry, ensuring standardized inputs across diverse clinical and research scenarios.

• Hearing Level (HL) Audiogram Corrections
  The amendment provides updated formulas for adapting audiograms obtained with insert earphones and various earpieces, facilitating accurate hearing loss assessment linked to real-ear acoustics.

• Technical Equations and Models
  The document revises specific mathematical expressions used to estimate ear canal SPL and to adjust audiometric thresholds, reinforcing scientific rigor in hearing aid evaluation.

Applications

• Hearing Aid Development and Manufacturing
  Manufacturers use SIST EN 61669:2016/A1:2025 to verify product performance meets strict acoustical standards, ensuring devices deliver effective amplification tailored to individual ear acoustics.

• Audiological Testing and Fitting
  Clinicians rely on the standard for real-ear measurements during hearing aid fitting, optimizing device settings to match patient’s unique ear canal acoustics for improved hearing outcomes.

• Research and Innovation
  Researchers in audiology and acoustic engineering adopt this standard to enable consistent, reproducible testing, facilitating innovation and benchmarking in hearing aid technology.

• Quality Assurance and Compliance
  The standard forms the basis for regulatory compliance across European markets, as CENELEC members incorporate it into national standards by the 2026 implementation deadline.

Related Standards

• IEC 61669:2015
  The parent international standard specifying the original methodology for real-ear acoustical performance measurement of hearing aids.

• ISO/IEC Directives
  Governing the development and harmonization of international standards, ensuring cohesive cooperation between IEC and ISO.

• EN 60118 Series
  Include standards on hearing aid compatibility and electroacoustic characteristics that complement EN 61669 requirements.

• EN 60601 Series
  Standards covering medical electrical equipment safety, often referenced alongside hearing aid performance standards.

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Key Keywords: real-ear measurement, hearing aids acoustical performance, EN 61669 amendment, electroacoustics standards, hearing aid testing, audiometric correction, CENELEC standards, IEC hearing aid measurement, hearing aid fitting accuracy, ear canal sound pressure level.

SIST EN 61669:2016/A1:2025 plays a vital role in ensuring hearing aids are assessed under realistic acoustic conditions, promoting higher user satisfaction and efficacy of hearing rehabilitation devices across Europe and globally.

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2025
Elektroakustika - Meritve akustičnih karakteristik slušnih pripomočkov v
človeškem ušesu - Dopolnilo A1 (IEC 61669:2015/AMD1:2025)
Electroacoustics - Measurement of real-ear acoustical performance characteristics of
hearing aids (IEC 61669:2015/AMD1:2025)
Elektroakustik - Messung der Kenndaten von Hörgeräten am menschlichen Ohr (IEC
61669:2015/AMD1:2025)
Électroacoustique - Mesure des caractéristiques de performances acoustiques des
appareils de correction auditive sur une oreille réelle (IEC 61669:2015/AMD1:2025)
Ta slovenski standard je istoveten z: EN 61669:2016/A1:2025
ICS:
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
17.140.50 Elektroakustika Electroacoustics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 61669:2016/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM February 2025
ICS 17.140.50
English Version
Electroacoustics - Measurement of real-ear acoustical
performance characteristics of hearing aids
(IEC 61669:2015/AMD1:2025)
Électroacoustique - Mesure des caractéristiques de Elektroakustik - Messung der Kenndaten von Hörgeräten
performances acoustiques des appareils de correction am menschlichen Ohr
auditive sur une oreille réelle (IEC 61669:2015/AMD1:2025)
(IEC 61669:2015/AMD1:2025)
This amendment A1 modifies the European Standard EN 61669:2016; it was approved by CENELEC on 2025-02-21. CENELEC members
are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the status of a
national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Türkiye and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 61669:2016/A1:2025 E

European foreword
The text of document 29/1179/CDV, future edition 2 of IEC 61669/AMD1, prepared by TC 29
"Electroacoustics" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2026-02-28
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2028-02-29
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 61669:2015/AMD1:2025 was approved by CENELEC as a
European Standard without any modification.

IEC 61669 ®
Edition 2.0 2025-01
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Electroacoustics – Measurement of real-ear acoustical performance

characteristics of hearing aids

Électroacoustique – Mesure des caractéristiques de performances acoustiques

des appareils de correction auditive sur une oreille réelle

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 17.140.50  ISBN 978-2-8327-0136-2

– 2 – IEC 61669:2015/AMD1:2025
© IEC 2025
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
ELECTROACOUSTICS –
MEASUREMENT OF REAL-EAR ACOUSTICAL
PERFORMANCE CHARACTERISTICS OF HEARING AIDS

AMENDMENT 1
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national
...