H90.6
Conditions
Interventions
Group 1: Audéo™ I-Sphere (performance level 90) will be used as investigational device for the entire study. All test features can be directly selected via the fitting software. Comparison: For the 3D
Sponsors
Sonova AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Experienced (minimum use duration 6 months) • Adult (minimum age: 18 years) hearing aid users • Written and spoken German, • Ability to understand instruction, • Ability to perform tests successfully • Ability to describe listening experiences, • Ability to attend to the appointments, • Healthy outer ear, • Moderate/severe Hearing loss • Informed consent as documented by signature.
Exclusion criteria
Exclusion criteria: • Clinical contraindications deformity of the ear (closed ear canal or absence of pinna), • Known hypersensitivity or allergy, • Not willing to wear the hearing aid, • Fluctuating hearing that could influence the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective (1) is to evaluate whether the Audéo™ I-Sphere with 3D noise cancellation (3DNC) activated provides better spontaneous speech intelligibility for turn-taking talkers in a complex noise situation than with StereoZoom activated for people with moderate/severe hearing loss (N4). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are: (2) to evaluate whether the Audéo™ I-Sphere with 3DNC activated provides lower cognitive load in a complex noise situation with competing talkers than with StereoZoom activated for people with moderate/severe hearing loss (N4). The cognitive load is measured with the CCOLSA#1. (3) to evaluate whether the Audéo™ I-Sphere with 3DNC activated provides better spontane-ous speech reception thresholds (SRTs) in a complex listening situation with target talkers from different directions in the frontal hemisphere than with StereoZoom activated for people with moderate/severe hearing loss (N4). The spontaneous speech reception thresholds are measured with the Spatial OLSA. (4) to evaluate whether the Audéo™ I-Sphere with 3DNC activated leads to reduced subjec-tive fatigue after the series of complex noise situations with competing talkers than with Ste-reoZoom activated for people with moderate/severe hearing loss (N4). The listening effort is measured with the LEFA. (5) to evaluate whether the Audéo™ I-Sphere with 3DNC activated provides lower cognitive load in complex noise situations with competing talkers leading to less fatigue at the end of a time-compressed auditory day than with StereoZoom activated for people with moderate/se-vere hearing loss (N4) The cognitive load is measured with the CCOLSA#1. (6) to evaluate whether the Audéo™ I-Sphere with 3DNC activated is preferred in noisy situ-ation over with StereoZoom activated for people with moderate/severe hearing loss (N4). The preference is determined with the EMA. (7) to evaluate how the Audéo™ I-Sphere is perceived in everyday life for people with moder-ate/severe hearing loss (N4). The spontaneous acceptance is measured using the spontane-ous acceptance questionnaire. (8), um zu bewerten, ob das Audéo™ I-Sphere mit aktiviertem 3DNC die Höranstrengung in einer komplexen Geräuschsituation mit konkurrierenden Sprechern im Vergleich zu aktiviertem StereoZoom für Menschen mit mittl | — |
Countries
Germany
Contacts
Public ContactJan Heeren
Hörzentrum Oldenburg gGmbH
Outcome results
None listed