Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

CompletedOBSERVATIONAL
Enrollment

57

Participants

Timeline

Start Date

March 16, 2021

Primary Completion Date

June 8, 2021

Study Completion Date

June 8, 2021

Conditions
Hearing Loss, ConductiveHearing Loss MixedHearing DisabilityConductive Hearing LossEar DiseasesConductive Hearing Loss, BilateralConductive Hearing Loss, Unilateral
Interventions
DEVICE

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.

DEVICE

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

DEVICE

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

DEVICE

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."

DEVICE

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

DEVICE

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.

DEVICE

Collection of power-on usage time with Ponto 3 SuperPower

Average power-on usage hours from Ponto 3 SuperPower will be collected.

Trial Locations (1)

NR4 7UY

Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Oticon Medical

INDUSTRY

NCT04803279 - Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear | Biotech Hunter | Biotech Hunter