đź“‹ FDA Reference
philips m30 in-the-ear hearing aid
Philips Hearing Instruments
Summary: The Philips M30 is an in-the-ear hearing aid designed to assist individuals with hearing impairment. It is used by audiologists and hearing specialists to improve auditory function in patients with mild to moderate hearing loss.
FDA Clearance Information
Pathway
510K
Number
K912339 ↗
Decision Date
June 7, 1991
Product Code
ESD
Device Class
Class 1
Evidence
419 studies
The Philips M30 In-the-Ear Hearing Aid was cleared through the FDA's 510(k) pathway on June 7, 1991. Manufactured by Philips Hearing Instruments, it is classified as a Class 1 device under product code ESD.
What It Is
The Philips M30 is a customizable in-the-ear hearing aid that amplifies sound for individuals with hearing loss. It fits directly into the ear canal, making it discreet and comfortable for daily use. The device is designed to enhance sound clarity and volume, helping users to better perceive speech and environmental sounds.
Clinical Applications
This hearing aid is commonly used in audiology clinics and hearing centers. It is suitable for adults and older children with mild to moderate hearing loss. Audiologists prescribe and fit these devices to improve patients' quality of life by enhancing their ability to communicate effectively in various settings, such as at home, work, or social gatherings.
Indications for Use
The FDA indications suggest that this device is intended for individuals experiencing hearing impairment. It is specifically designed to assist those with mild to moderate hearing loss, providing them with improved auditory perception.
Practical Considerations
The Philips M30 is typically available in various sizes to fit different ear shapes and sizes. It is important for clinicians to ensure proper fitting and customization for optimal performance. Compatibility with other hearing accessories should be verified during fitting sessions.
Linked Studies (20)
PubMed • 2025
Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.
Journal of neuroendovascular therapy
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.
Clinical chemistry and laboratory medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical progress note: Haemophilus influenzae type b.
Journal of hospital medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Pilot study of social media promotion of home-based self-testing for syphilis.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.
Journal of clinical microbiology
View Source →
PubMed • 2025
Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.
Sexually transmitted diseases
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.
Florida public health review
View Source →
PubMed • 2025
Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.
Frontiers in cellular and infection microbiology
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.
Transboundary and emerging diseases
View Source →
PubMed • 2025
Tp40: a new potential prognostic and diagnostic marker for syphilis.
Microbiology spectrum
View Source →
PubMed • 2025
Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.
The Journal of clinical investigation
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.
Hellenic journal of nuclear medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.
Biochemistry and cell biology = Biochimie et biologie cellulaire
View Source →
PubMed • 2025
Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.
Journal of Yeungnam medical science
RCT View Source →
PubMed • 2025
pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.
Magnetic resonance in medicine
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Comparative connectomics of Drosophila descending and ascending neurons.
Nature
RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025
Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.
Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences
View Source →
PubMed • 2025
History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.
Zeitschrift fur Rheumatologie
View Source →
PubMed • 2025
A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.
BioMed research international
RCT|prospective|retrospective|case Series|other View Source →Frequently Asked Questions
What is Philips M30 In-the-Ear Hearing Aid used for?
It is used to amplify sound for individuals with mild to moderate hearing loss, improving their ability to hear and communicate.
What specialties typically use this device?
Audiologists and hearing specialists commonly use this device in audiology clinics and hearing centers.
What are the FDA-cleared indications?
The device is indicated for individuals with mild to moderate hearing loss to improve auditory perception.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.