An audiometry test, also known as a hearing test, evaluates your ability to hear sounds. The test uses different sounds of varying volume and pitch, delivered one ear at a time, through headphones or earplugs. You'll be asked to respond by pressing a button or raising your hand each time you hear a sound. The test can indicate sensorineural hearing loss, which is damage to the cochlea or nerve, or conductive hearing loss, which is damage to the eardrum or ossicle bones.

Audiograms are over 90% accurate and can identify and measure hearing loss within five decibels of the actual level.

Pure-tone audiometry is a type of audiometry test that measures an individual's hearing thresholds for pure tones at various frequencies, typically ranging from low to high frequencies. Pure tone audiometry employs both air and bone conduction techniques to assess hearing loss. 

Speech audiometry evaluates an individual's ability to understand speech by measuring their speech recognition or discrimination scores in response to spoken words or sentences presented at different intensity levels. 

Common audiometry tests include pure-tone audiometry, speech audiometry, tympanometry, otoacoustic emissions (OAE) testing, speech testing, and auditory brainstem response (ABR) testing.

Audiometry equipment should comply with regulatory standards such as HIPAA, HL7, and IEC 60645 to ensure patient data security and device reliability.

Audiometric medical device companies must adhere to several standards and compliances to ensure the safety, efficacy, and quality of their products. Some of the key standards and compliances include:

• ISO 13485: This is an international standard for quality management systems specific to the medical device industry. Compliance with ISO 13485 demonstrates the company's commitment to maintaining quality throughout the design, development, production, and distribution of medical devices.
• FDA Regulations: In the United States, audiometric medical device companies must comply with regulations set forth by the Food and Drug Administration (FDA). This includes premarket clearance or approval for devices, adherence to Good Manufacturing Practices (GMP), and compliance with post-market surveillance requirements.
• IEC 60601: This international standard specifies safety and essential performance requirements for medical electrical equipment. Audiometric devices fall under the scope of IEC 60601, and compliance ensures the safety and performance of these devices.
• HL7 Standards: Health Level Seven International (HL7) develops standards for the exchange, integration, sharing, and retrieval of electronic health information. Compliance with HL7 standards ensures interoperability and seamless data exchange between audiometric devices and other healthcare systems.
• HIPAA Compliance: The Health Insurance Portability and Accountability Act (HIPAA) sets standards for the protection of patients' protected health information (PHI). Audiometric medical device companies must comply with HIPAA regulations to ensure the confidentiality and security of patient data.
• IEC 62304: This standard specifies requirements for the lifecycle processes of medical device software. Compliance with IEC 62304 ensures the development of safe and effective software for audiometric devices.
• Noah System: Noah is a software standard used in audiology for hearing care providers. Compliance with Noah ensures compatibility and interoperability between audiometric devices and patient management systems.

Decos has extensive experience in understanding and ensuring that medical device manufacturing companies meet the necessary compliances.

Audiometry software solutions are specialized software applications designed to assist healthcare professionals in diagnosing and managing conditions affecting hearing, balance, and sensory functions. Audiometry software solutions streamline the process of conducting audiometric tests, managing patient data, and generating comprehensive reports, leading to more efficient workflows and improved patient care.

AI-driven technology enhances diagnostic accuracy by providing advanced data analysis and predictive modeling capabilities, personalizing patient care and leading to more precise results.

Audiometry software solutions include features such as audiometric testing modules, patient data management tools, customizable reporting options, integration with diagnostic equipment, and compatibility with electronic medical record (EMR) systems. Decos provides specialized services to develop, re-engineer, and enhance audiometry software solutions. We ensure the solutions delivered are compliant with international standards and EMR/EHR ready.