Hearing Aids Industry Terminology

Acoustic Feedback

Unwanted whistling/howling caused by a loop between the receiver output and microphones, often due to leakage, venting, or poor fit. Modern aids use adaptive cancellation to mitigate it.

- Increased vent size reduced acoustic feedback during speech - The feedback manager added 10 dB of stability margin - Patient reported whistling when hugging; we tightened the earmold fit

ANSI S3.22

U.S. standard defining electroacoustic measurement methods for hearing aids (e.g., OSPL90, gain, distortion, equivalent input noise) to ensure comparable performance reporting.

- Spec sheet OSPL90 measured per ANSI/ASA S3.22-2014 - QC lab calibrates couplers to meet ANSI S3.22 tolerances - EIN and HFA data reported under ANSI S3.22 methodology

Audiogram

Graph of hearing thresholds (dB HL) across frequency for each ear, obtained via pure-tone audiometry and used to diagnose hearing loss and set prescriptive targets.

- Sloping high-frequency loss on the audiogram guided frequency lowering - Imported the audiogram from NOAH into fitting software - Air-bone gap on the audiogram indicated a conductive component

Audiologist

Licensed hearing healthcare professional who assesses hearing, fits and verifies hearing aids, and provides counseling and rehabilitation.

- The audiologist verified the fitting with REM - Audiologist counseled on realistic outcome expectations - Referral from the audiologist to ENT for asymmetric loss

Automatic Gain Control (AGC)

Automatic adjustment of amplification to keep output within a comfortable range. Uses thresholds and time constants to manage soft, medium, and loud inputs.

- Increased AGC kneepoint to preserve soft speech audibility - Adjusted attack/release times for comfort in impulsive noise - AGC limited sudden loud sounds to avoid discomfort

Average Selling Price (ASP)

The average realized price per device after discounts, rebates, and mix. A key revenue and pricing metric by channel and geography.

- Mix shift toward OTC reduced ASP year over year - Bundling services increased ASP in the clinic channel - Promotions compressed ASP in Q4

Beamforming

Microphone array processing that emphasizes sounds from a target direction while attenuating others to improve speech understanding in noise.

- Adaptive beamforming improved SNR in a restaurant - Narrow-beam mode engaged in the ‘speech focus’ program - Beamforming strength was reduced for music listening

Behind-The-Ear (BTE)

Hearing aid style with the processor and battery housed behind the ear and sound delivered via tubing to an earmold or eartip.

- Pediatric fittings often use BTEs for flexibility and safety - Switched to power BTE for severe-to-profound loss - Thin-tube BTE improved cosmetics and comfort

Binaural Processing

Coordinated processing between the left and right devices (via wireless link) to preserve spatial cues, align features, and improve speech in noise.

- Binaural synchronization aligned program changes across ears - Cross-ear noise reduction balanced the scene - Binaural streaming delivered phone calls to both ears

Bluetooth Low Energy (BLE)

Low-power wireless standard used for control and audio streaming (with LE Audio) between hearing aids and phones, TVs, and accessories.

- BLE pairing through the app simplified setup - LE Audio support reduced streaming latency and power - Firmware update enabled BLE audio broadcasting

CE Marking

European conformity marking indicating a device meets applicable EU health, safety, and performance requirements (e.g., MDR for hearing aids).

- Device CE-marked under EU MDR with PMS plan - Clinical evaluation report updated for CE renewal - Distributor requires CE documentation for import

Cerumen Management

Practices and accessories (e.g., wax guards) to prevent earwax from occluding the canal or damaging receivers and microphones.

- Implemented wax guard replacements every 4 weeks - Cerumen obstruction caused intermittent feedback - Clinic added cerumen removal service to reduce repairs

CIC (Completely-in-Canal)

Custom in-the-ear style that fits deeply in the ear canal, offering discretion but with constraints on battery, power, and wireless features.

- Patient chose CIC for cosmetic reasons - CICs have limited connectivity due to size - Vent size in the CIC adjusted to reduce occlusion

Digital Signal Processing (DSP)

Onboard processing of audio using algorithms for compression, noise reduction, directionality, feedback control, and connectivity.

- DSP pipeline includes WDRC, NR, and feedback cancellation - DSP headroom limited additional features this cycle - New DSP enables on-device AI scene analysis

Directionality

Control of microphone pickup patterns (omnidirectional, fixed, or adaptive) to enhance signals from desired directions and suppress noise.

- Automatic directionality adapted to multi-talker noise - Fixed cardioid pattern used for lecture mode - User toggled omni to improve music fidelity

Domes (Eartips)

Disposable silicone tips that couple RIC/thin-tube hearing aids to the ear canal; available in open, closed, and power designs affecting acoustics.

- Switched from open to closed dome to increase gain - Double-dome improved retention and feedback stability - Stocking standard domes reduced fitting lead times

Earmold

Custom ear canal/ear bowl coupling made from impressions. Materials, bore, and venting affect acoustics, comfort, and feedback.

- Acrylic skeleton earmold with 1.5 mm vent - Earmold remake resolved feedback and comfort issues - Pediatric BTE with soft earmold for retention

FDA 510(k)

U.S. FDA premarket notification demonstrating substantial equivalence for Class II hearing aids and related accessories when required.

- Cleared via 510(k) with a predicate power BTE - Design changes assessed for 510(k) applicability - OTC devices that are non-exempt still need 510(k)

Feedback Cancellation

Algorithm that estimates and cancels the acoustic feedback path to prevent whistles while maintaining stable, natural sound.

- DFS calibration reduced whistling at high gain - Adaptive notch filter tracked feedback paths in real time - Increased feedback margin by 8 dB after refit

Frequency Lowering

Techniques (compression or transposition) that move high-frequency content to lower frequencies to improve audibility when bandwidth is limited.

- Activated frequency compression for ski-slope loss - Start frequency set at 3 kHz improved /s/ audibility - Patient preferred transposition over compression

Gain

Amount of amplification applied to input signals, typically frequency-specific and level-dependent per prescriptive targets.

- Increased high-frequency gain by 4 dB to meet target - Adjusted gain handles to balance loudness - Verified insertion gain against NAL-NL2 targets

IEC 60118

International standards series for hearing aid electroacoustic measurements and performance specifications.

- Measured OSPL90 per IEC 60118-7 in 2 cc coupler - EIN calculated following IEC method - Wireless tests referenced IEC 60118-13 guidance

Ingress Protection (IP Rating)

Rating system (e.g., IP67, IP68) that indicates resistance to dust and water ingress to improve reliability and durability.

- IP68 rating highlighted in marketing claims - Sweat ingress tests validated IP performance - Service denied water-damage claim beyond IP spec

In-Situ Audiometry

Measuring hearing thresholds through the hearing aids themselves in the user’s ear to personalize fitting without a sound booth.

- In-app in-situ testing enabled self-fitting flow - In-situ thresholds refined prescriptive targets - Detected threshold shift vs booth audiogram

ISO 13485 (Quality Management System)

International QMS standard for medical devices covering design controls, risk management, CAPA, and documentation.

- Supplier certification to ISO 13485 required - CAPA and design controls audited under ISO 13485 - Transitioned QMS to align with MDR and ISO 13485

MFi (Made for iPhone) Hearing Aids

Apple certification program enabling direct control and audio streaming between iOS devices and supported hearing aids.

- Paired via iOS Accessibility under MFi devices - MFi streaming reduced latency on phone calls - Certification updated to the latest MFi specs

NAL-NL2 (Prescriptive Target Formula)

Widely used prescriptive fitting rule that sets frequency- and level-dependent targets for gain and output in adults.

- Fit adult patient to NAL-NL2 targets - Compared outcomes of NAL-NL2 vs DSL v5 - REM showed close match to NAL-NL2 at 2–4 kHz

NOAH (HIMSA)

Industry-standard software framework/database from HIMSA that allows different manufacturers’ fitting modules to interoperate in clinics.

- Imported historical fittings from NOAH 4 - Vendor’s NOAH module updated for new features - Clinic backed up the NOAH database weekly

Noise Reduction (NR)

Algorithms that reduce steady-state and modulated background noise while aiming to preserve speech, improving listening comfort.

- Aggressive NR selected for ‘comfort’ program - Deactivated NR in music mode to preserve fidelity - NR strength tuned per channel and scene

Occlusion Effect

Booming or hollow perception of one’s own voice due to sealed ear canals; mitigated by venting, deeper fit, or processing.

- Increased vent diameter to reduce occlusion - Patient counseled on occlusion adaptation - REOG confirmed reduction in occlusion resonance

OSPL90

Output Sound Pressure Level for a 90 dB SPL input; measures maximum output in a 2 cc coupler and informs comfort/safety limits.

- HFA-OSPL90 listed on the datasheet - Verified OSPL90 against specification in coupler - Ensured OSPL90 below regulatory maximum output

OTC Hearing Aids

U.S. category allowing adults with perceived mild-to-moderate hearing loss to buy and self-fit hearing aids without a prescription.

- Launched OTC line for mild-to-moderate losses - Retailer added OTC displays near pharmacy - Return policies adapted for OTC purchases

PSAP (Personal Sound Amplification Product)

Consumer audio amplifiers for recreational use; not medical devices and not intended to compensate for hearing impairment.

- Clarified PSAPs are not for treating hearing loss - PSAPs marketed for hunting and birding - Avoided regulatory risk by not labeling PSAP as OTC

QuickSIN (Speech-in-Noise Test)

Clinical test that estimates SNR loss by measuring how much additional SNR a listener needs to understand sentences in noise.

- QuickSIN improved by 3 dB after reprogramming - Baseline QuickSIN taken before fitting - Used QuickSIN to counsel on expected outcomes

Real Ear Measurement (REM)

Probe-microphone verification of in-ear output (REAR/REIG) to confirm that amplification meets prescriptive targets in the wearer’s ear.

- Verified REAR matched targets within ±3 dB - REM revealed under-amplification at 4 kHz - Used REIG for BTE with earmold coupling

Receiver-In-Canal (RIC)

Hearing aid style with the receiver located in the ear canal connected by a thin wire to a small behind-the-ear processor.

- RIC models dominate unit volume in many markets - Swapped to a power receiver to reach targets - Sport lock added for RIC retention

Rechargeable Lithium-Ion Battery

Integrated rechargeable cell technology that replaces disposable zinc-air batteries, enabling sealed designs and daily charging.

- All-day battery life with Li-ion rechargeables - Added contactless charging case to the lineup - Evaluated UN 38.3 shipping requirements for Li-ion

Remote Programming (Teleaudiology)

Providing fitting adjustments and follow-up care remotely through connected apps and cloud services, either synchronous or asynchronous.

- Asynchronous remote fine-tuning via app - Live video sessions for synchronous adjustments - Expanded access to rural patients with telecare

SaMD (Software as a Medical Device)

Software intended for medical purposes without being part of a hardware medical device; may include fitting, diagnostics, or therapy features.

- Self-fitting algorithm classified as SaMD - Documented lifecycle per IEC 62304 for SaMD - Regulatory update required for SaMD change control

Self-Fitting

User-driven process to configure the hearing aid (often using in-situ tests and automated target setting) without clinician intervention.

- In-app guided self-fitting validated in trials - Self-fitting workflow included in OTC product - Customer support trained on self-fitting issues

Signal-to-Noise Ratio (SNR)

Ratio of desired signal (speech) level to background noise level; a key determinant of intelligibility in real-world listening.

- Beamforming improved SNR by 4 dB in cafeteria - Counseling: patient needs +8 dB SNR to follow speech - NR and directionality strategies target SNR gains

Target Gain

Frequency- and level-specific amplification prescribed by fitting formulas that guides programming and verification.

- Matched target gain within 3 dB across bands - Adjusted compression to reach targets at 65 dB SPL - Targets differed between NAL-NL2 and DSL

Telecoil

Inductive pickup coil in hearing aids that receives signals from hearing loops and some telephones for improved clarity in venues.

- Enabled T-coil program for the theater loop - Magnet detection switches to telecoil near handset - Verified telecoil performance per IEC methods

Third-Party Administrator (TPA)

Intermediary organization managing hearing benefits, pricing, and provider networks for insurers and large employers.

- TPA contract set fixed reimbursement rates - TPA network access boosted patient flow - TPA fees reduced clinic margin per fit

Tinnitus Sound Therapy

Use of sound generators and tailored noise programs within hearing aids to reduce the perception or distress of tinnitus.

- Activated tinnitus masker with ocean noise - Matched therapy to patient’s tinnitus pitch - Promoted tinnitus features in marketing

Trial Period (Return Policy)

The window during which users can return or exchange hearing aids; policies vary by jurisdiction and channel.

- State law mandates a 45-day trial - Return-for-credit rates tracked monthly - Counseled patients on trial expectations

UDI (Unique Device Identification)

Global system for uniquely identifying medical devices via standardized identifiers on labels, packaging, and databases.

- Added UDI-DI on label and packaging - Submitted records to FDA GUDID database - Tracked field actions using UDI data

WDRC (Wide Dynamic Range Compression)

Compression strategy that provides more gain for soft sounds and less for loud sounds to fit environmental sounds into the listener’s reduced dynamic range.

- Increased compression ratio for soft inputs - Fast WDRC improved consonant audibility - Balanced WDRC for comfort and clarity

Wax Guard

Small replaceable filter that protects the receiver opening from cerumen and debris, reducing failures and service events.

- Replaced clogged wax guard to restore sound - Monthly wax guard changes reduced receiver failures - Training included wax guard maintenance

Zinc-Air Battery

Primary button-cell battery chemistry activated by air; common sizes include 10, 312, 13, and 675 for hearing aids.

- Size 312 zinc-air used in most RICs - Waited 1 minute after pulling tab to activate - Altitude and dryness affected zinc-air performance