Audiometer calibration is the single most critical quality control activity in any audiology practice. Without regular, standards-compliant calibration, hearing threshold data is unreliable — leading to misdiagnosis, failed audits, and legal exposure. ANSI S3.6 is the governing standard in the United States, and understanding what it requires is essential for every audiologist, practice manager, and hospital equipment coordinator.
What is ANSI S3.6?
ANSI S3.6, published by the American National Standards Institute, defines the electroacoustic performance specifications that audiometers must meet to produce valid hearing threshold data. The current edition is ANSI S3.6:2018.
The standard specifies reference equivalent threshold sound pressure levels (RETSPLs) for each transducer type — insert earphones, supra-aural earphones, circumaural headphones, and bone conduction vibrators — at each test frequency. It also sets tolerances for pure-tone frequency accuracy, harmonic distortion, attenuator linearity, and masking noise levels.
Governing Standard
ANSI S3.6:2018 — Specification for Audiometers. IEC 60645-1 is the equivalent international standard and is largely harmonized with ANSI S3.6.
Annual vs. Exhaustive Calibration
ANSI S3.6 defines two levels of calibration. An exhaustive calibration — also called a full electroacoustic calibration — is a comprehensive measurement of all audiometer output parameters against the full set of standard tolerances. It must be performed by a calibrated laboratory using NIST-traceable equipment.
An annual calibration (sometimes called a periodic or limited calibration) verifies a subset of critical parameters — primarily output levels at key frequencies, attenuator linearity, and frequency accuracy. This is performed annually at minimum, and additionally any time the audiometer is dropped, repaired, or produces questionable results.
- Exhaustive calibration: every 2 years minimum, or after repair
- Annual calibration: every 12 months minimum
- Listening check: every test day, by the clinician
- Biological calibration: weekly, using a staff member with known thresholds
SPL Output Tolerances
The allowable deviation from the reference output level varies by frequency. At 1000 Hz, the tolerance is ±3 dB. At frequencies above 4000 Hz, the tolerance widens to ±5 dB due to the increased variability in coupler and transducer behavior at higher frequencies.
It is important to note that these tolerances apply to the audiometer output level as measured at the transducer using the specified coupler — not to the patient's perceived loudness. A properly calibrated audiometer ensures that a 0 dB HL stimulus represents normal hearing level as defined by the standard.
Tolerance Summary
250–1000 Hz: ±3 dB. 1500–4000 Hz: ±3 dB (insert earphones) or ±5 dB (supra-aural). 6000–8000 Hz: ±5 dB. Bone conduction: ±5 dB.
Harmonic Distortion Limits
ANSI S3.6 requires that harmonic distortion in the pure-tone output does not exceed 3% at output levels at or below 75 dB HL, and does not exceed 5% at levels above 75 dB HL. Distortion above these limits introduces spectral splatter that can produce artifactual thresholds, particularly at adjacent frequencies.
Distortion Failure Mode
Audiometers with worn transducers or aging amplifier stages are the most common source of distortion failures. If a patient reports hearing a buzzing or rough quality to tones, request an immediate out-of-cycle calibration check.
Calibration Intervals and When to Calibrate Early
The one-year interval is a minimum, not a target. High-volume clinics testing 20 or more patients per day should consider six-month calibration cycles given the cumulative mechanical wear on transducers.
Calibration should be performed immediately — regardless of the scheduled interval — whenever an audiometer is dropped or physically impacted, when test results are inconsistent with patient history, when the clinic fails an external audit, or when insert earphone tubing is replaced.
- After any physical impact or drop event
- After repair or any internal adjustment
- After transducer replacement
- When patient results are clinically implausible
- Before a JCAHO, CMS, or ASHA accreditation survey
Documentation Requirements
A valid calibration certificate must include the instrument make, model, and serial number; the date of calibration; the measured values at each frequency and transducer; the reference values from the standard; the pass/fail result for each parameter; the measurement uncertainty; and the name and accreditation status of the performing laboratory.
Certificates should be retained for a minimum of three years and made available on request during accreditation surveys. Digital storage with versioned backups is strongly recommended.
Choosing an Accredited Calibration Laboratory
Not all calibration services are equal. A laboratory performing audiometer calibration should hold ISO 17025 accreditation from a recognized national accreditation body and should use NIST-traceable reference standards. Ask any prospective laboratory for their scope of accreditation, which specifies the exact measurement parameters and uncertainty values they are accredited to perform.
What to Ask Your Calibration Lab
Request their ISO 17025 accreditation certificate, their current calibration uncertainty budget, and a sample certificate. A reputable lab will provide these without hesitation.
Frequently Asked Questions
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