Auditory, function screening devices, newborn

Auditory, function screening devices, newborn
Alternative names
Neonatal or Newborn Hearing Screening.
Primary use
Diagnosis / Measurement / Monitoring
Type of medical device or related product
Medical equipment
General vs. specific use (health condition)
Specific
Intended population age
Neonatal
Childhood (28 days to 9 years)
Intended population sex
All
Level of technical knowledge
Specialized clinical
Capital
Yes
Reusable
Yes
Requirements
electricity (batteries)
electricity (mains)
WHO list of priority medical devices
Reproductive, maternal, newborn and child health (2015)
Service delivery platforms / Healthcare levels
Second-level and third-level hospital services and specialized outpatient services
Healthcare unit
Specialized diagnostics
EMDN related code(s)
Z12149001
OTOACOUSTIC EMISSIONS EQUIPMENT
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdn
GMDN related code(s)
58019
Otoacoustic emission system, battery-powered (An assembly of battery-powered devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure-tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a portable programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).)
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024 
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