Unilateral or bilateral conductive hearing loss, or mixed conductive and sensorineural hearing loss with previous implantatation of a Sophono-implant in one or both ears
Conditions
Interventions
Group 1: Patients with conductive or mixed hearing loss who have previously been fitted with a so-called Sophono implant will be fitted with a new audioprocessor or bone conducting implant, depending
Sponsors
Klinik für Hals-, Nasen-, Ohren- Heilkunde, Kopf- und Hals-Chirurgie; Stiftungsklinikum PROSELIS gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Unilateral or bilateral, relatively stable conductive hearing loss, or mixed conductive and sensorineural hearing loss • Presence of a cochlear implant in one or both ears • Bone conduction threshold of 20 dB • Suitability for all examinations required for the study • Signed and dated consent form
Exclusion criteria
Exclusion criteria: • Mixed conductive and sensorineural hearing loss (sensorineural threshold >45 dB) • Retrocochlear or central hearing loss • Known intolerance to the materials • Skin conditions, particularly of the scalp, which prevent the wearing of the audioprocessor or interfere with its use • Any physical, psychological or emotional condition that impedes the ability to undergo audiological examinations or to use the audio processor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Pure-tone audiometric hearing thresholds in decibels across a range of frequencies from 125 to 8000 Hz via air and bone conduction (funtional gain curve) (at the initial examination and 1, 2, 4 and 7 months after refitting) -Single-syllable and number comprehensiontest in the free field S0N0 (Freiburg Speech Test) at 65 dB (at the initial examination and 2, 4 and 7 months after fitting) -The speech intelligibility threshold as the signal-to-noise ratio in decibels in a free-field setting with background noise (S0N0) (Oldenburg Sentence Test) (At the initial examination and 4 and 7 months after fitting) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Subjective hearing performance as a score based on the SSQ12 (Speech, Spatial and Qualities of Hearing Short Form SSQ12 Item Score) -Satisfaction with the audio processor or psychosocial strain as a score based on the APSQ (Athlete Psychological Strain Questionnaire) -Perceived quality of life/subjective health as a score based on the AQoL-8D questionnaire (Assessment of Quality of Life – 8 Dimensions) (All the above tests are carried out at the initial examination and again 7 months after fitting) | — |
Countries
Germany
Contacts
Public ContactMagnus Teschner
Klinik für Hals-, Nasen-, Ohren- Heilkunde, Kopf- und Hals-Chirurgie; Stiftungsklinikum PROSELIS gGmbH
Outcome results
None listed