57
Participants
Start Date
March 16, 2021
Primary Completion Date
June 8, 2021
Study Completion Date
June 8, 2021
Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower
Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.
Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower
BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted
Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower
Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post fitting, alternatively from the fitting visit. Thresholds will be obtained aided, and when available unaided
Collection of speech intelligibility scores
"Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at Norwich and Norfolk hospital is the BKB (Bamford-Kowal-Bench) and/or the The AB\[s\] Isophonemic Monosyllabic Word test (7).~The sentence tests are measured in quiet and/or with background speech-weighted noise."
Skin reaction
Classification of skin reactions around skin penetrating implants will be made using the Holgers score. The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions
Collection of Glasgow Benefit Inventory
The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of Ponto 3 SuperPower on abutment.
Collection of power-on usage time with Ponto 3 SuperPower
Average power-on usage hours from Ponto 3 SuperPower will be collected.
Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich
Lead Sponsor
Oticon Medical
INDUSTRY