(70 days)
Not Found
No
The description details traditional signal processing techniques (compression, frequency bands) and manual adjustments via trimmers and a volume dial. There is no mention of AI, ML, or learning algorithms.
Yes
The device is intended to compensate for hearing loss and includes features for loudness correction, compression, and amplification, indicating a therapeutic purpose.
No
The device is described as a wearable sound amplifying device to compensate for hearing loss, which is a treatment and not a diagnostic function.
No
The device description explicitly states that the electronics are contained in a custom plastic case and mentions hardware components like trimmers and a volume control dial, indicating it is a hardware device with embedded software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss." This describes a device that interacts with the user's external environment (sound) and provides a physical output (amplified sound) to aid a physiological function (hearing).
- Device Description: The description details the electronic components and how they process sound signals. It does not mention any interaction with biological samples (blood, urine, tissue, etc.) or the diagnosis of a disease or condition based on the analysis of such samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of analytes.
- Diagnosis, monitoring, or prediction of a disease or condition based on biological sample analysis.
This device is clearly a hearing aid, which is a medical device but falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Model WMR BTE is a dual-channel, wide-dynamic The range input instrument which allows for loudness correction compression by changing compression ratios within the two bands. The WMR separates incoming signals into high and low frequency bands which can be independently compressed prior to recombination and amplification. The electronics for the hearing instrument are contained in a custom plastic case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The user may adjust the gain (loudness) of the hearing instrument by rotating the volume control dial to his/her most comfortable listening level. This hearing instrument does not require a special fitting system; however, the trimmer controls may only be adjusted by an authorized hearing aid dispenser, NOT by the consumer.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data for this submission has been obtained in accordance w i t h the test procedures of the American National Standard Specification of Hearing Aid Characteristics, ANSI S3.22-1987 (Revision of S3.22-1982).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K943788, K935095, K953543, K951828
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
0
NOV 26 1996
510(k) SUMMARY
HEARING INNOVATIONS INCORPORATED MODEL WMR BEHIND-THE-EAR (BTE) HEARING INSTRUMENT
Telephone Number, Contact Person and Date Address, Submitter's Name, Prepared
Robert S. Green, President Hearing Innovations Incorporated 3567 East Sunrise Drive Suite #101 Tucson, Arizona 85718
Contact Person(s): Same as above
September 16, 1996 Date Prepared:
Name of Device and Name/Address of Sponsor
Model WMR Behind-The-Ear (BTE) Hearing Instrument
Innovations Incorporated Hearing 3567 East Sunrise Drive Suite #101 Tucson, Arizona 85718
Classification Name
The model WMR Behind-The-Ear (BTE) Hearing Instrument is among those devices commonly referred to as air conduction hearing aids. These devices have been classified by the Ear, Nose and Throat Classification Panel as Class I devices set forth in 21 CFR 874.3300
Action Taken to Comply With Performance Standards
Performance data for this submission has been obtained in accordance w i t h the test procedures of the American National Standard Specification of Hearing Aid Characteristics, ANSI S3.22-1987 (Revision of S3.22-1982).
1
Intended Use
: 参
Intended to be used as a wearable sound amplifying device to compensate for mild to severe hearing loss.
Product Description
Model WMR BTE is a dual-channel, wide-dynamic The range input instrument which allows for loudness correction compression by changing compression ratios within the two bands. The WMR separates incoming signals into high and low frequency bands which can be independently compressed prior to recombination and amplification. The electronics for the hearing instrument are contained in a custom plastic case.
The Model WMR BTE features three adjustable trimmers that can only be adjusted by the dispenser to meet individual patient requirements. The user may adjust the gain (loudness) of the hearing instrument by rotating the volume control dial to his/her most comfortable listening level. This hearing instrument does not require a special fitting system; however, the trimmer controls may only be adjusted by an authorized hearing aid dispenser, NOT by the consumer. Notes to this effect are included in the User Instruction Booklet included in this submission.
- The crossover frequency between the low band and high band channels; 1)
-
- High band compression ratio;
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- Low band compression ratio
Predicate Devices
The Model WMR BTE Hearing Instrument is substantially equivalent to the following successfully reviewed devices:
| ReSound Personal Hearing System-BT2 | K943788 |
|---|---|
| 3M 8260 Programmable Instruments | K935095 |
| 3M 8200 P Multipro BTE | K953543 |
| Siemens Full Dynamic Range Compression BTE | K951828 |
2
Substantial Equivalence Technological Characteristics and
Like its predicate devices, the Model WMR is a behind-the-ear (BTE) air conduction hearing aid which utilizes a standard hearing aid microphone and transduces sound into an electrical signal is processed, amplified and converted back to sound by a standard hearing aid receiver.
The technological characteristics available in the Model WMR BTE are similar to those in the predicate devices. Like the ReSound Personal Hearing System-BT2 WMR BTE offers wide dynamic range compression Model predicate, the The 3M predicates offer a ; the Model WMR BTE offers two bands of compression. two channel programmable AGC aid with flexibility to change the crossover frequency like the Model WMR. While the predicate devices utilize digital control of an analog signal, the Model WMR BTE is adjusted by the dispenser using the three available trimmers: the crossover frequency between the low band and high band channels; high band compression ratio; low band compression ratio. No special fitting system is required to program the device.
There are no technological differences between the Model WMR BTE and its predicate devices to raise any new issues of safety or efficacy.