Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.

• NH subjects
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Pure tone audiometry:
• Air-conduction hearing threshold at all frequencies ≤15dB.
• No air-bone-gap.
• Normal classical tympanometry: Jerger A (see fig. 1)
• CHL subjects
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Pure tone audiometry:
• Bone-conduction threshold at all frequencies ≤20dB.

• Two exceptions:

  • Age-related hearing loss: bone-conduction threshold ≤40dB in the higher frequencies (> 2kHz).
• Carhart notch: bone-conduction threshold >20dB around 2kHz. air-bone-gap ≥10dB at ≥ 1 frequency.
• CI recipients
• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
• At least 18 years of age at the time of signing the ICF.
• Ear is planned for CI surgery by treating ENT surgeon.
• Normal classical tympanometry: Jerger A.

Exclusion Criteria

• NH subjects
• Patient has history of extensive middle ear disease.
• Patient has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Severe otitis externa or occlusion of the external auditory canal
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• CHL subjects
• Patient has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Signs of structural pathological processes such as tumors, cysts or cholesteatoma.
• Severe otitis externa or occlusion of the external auditory canal
• Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• CI recipients
• ear has history of extensive middle ear disease.
• ear has history of middle ear surgery.
• Abnormal otoscopy showing signs of tympanic membrane perforation or middle ear effusion.
• Severe otitis externa or occlusion of the external auditory canal