Bone Anchored Hearing Aids, Hearing Loss
Conditions
Brief summary
This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.
Detailed description
The study is observational and non interventional and follows clinical practice at participating clinics with the only exception of three questionnaires given to consenting patients after surgery and during follow-up, after loading of the sound processor. The study is a combined retro- and prospective study. The retrospective part consists of a chart review of patients who have undergone Ponto-implantation out of OR from 2019 and onwards. The prospectively recruited subjects are patients who are planned to undergo Ponto-implantation surgery out-of-OR.
Interventions
DEVICEPonto implantation
Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.
Sponsors
Oticon Medical
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects (≥18 years old) undergoing Ponto implantation in an out-of-OR setting from 2019 and onwards * Signed informed consent (applicable for subjects answering questionnaires)
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative complications at surgery | During the Ponto-implantation surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of procedure room variables | 12 months after study start | To make an assessment of how procedure rooms that are used for Ponto out-of-OR surgeries look like. Will be measured using the 'Procedure room used for Out-of-OR Ponto-surgery questionnaire' |
| To assess surgical parameters | During Ponto-implantation surgery | With this outcome, the aim is to assess the surgical variables present during Ponto out-of-OR surgeries. A series of yes or no questions will be presented in a form to the surgeon regarding the use of anesthesia, sedatives, implants, and abutments of different lengths. The results will be presented in a table. |
| Evaluation of patient experience of surgical procedure based on Ponto procedure questionnaire | 5-10 days after Ponto surgery | Score is reported on a scale of 5 steps, were the lowest value (1) is the worst and the highest value is the best (5) |
| To assess postoperative events and complications | From day of surgery, through study completion, an average of 1 year | All postoperative events and complications will be presented in a descriptive table, listing how many were affected by each type of event or complication. |
| To assess rate of implant survival | 3 months after surgery, and through study completion, an average of 1 year. | Implant survival will be assessed at least once, at 3 months. If follow-up data is available, implant survival will be assessed through study completion, an average of 1 year. |
| To assess time from surgery to sound processor loading | Time from surgery to sound processor loading which happens at an average of 3 months after surgery. | — |
| To assess sound processor usage time | 3 months after surgery, and through study completion, an average of 1 year. | — |
| To assess effectiveness of hearing rehabilitation using IOI-HA questionnaire | 3 months after surgery | Will be assessed using the standardised questionnaire International Outcome Inventory for Hearing Aids (IOI-HA) score at 3 months post-surgery. In the questionnaire, each item has five response choices proceeding from the worst outcome to the best outcome (1-5). The score will be presented as mean score with, standard deviation and median for the two groups. |
| To assess patient-reported benefit after BAHS treatment using the questionnaire Glasgow Benefit Inventory (GBI) | 3 months after surgery | Glasgow Benefit Inventory (GBI) benefit scores will be presented for total-, general-, social- and physical scores at 3 months post-surgery. The GBI uses a scale from -100 to +100, where scores above 0 indicate improved quality of life. |
Countries
Brazil, Canada, Spain, Sweden, United States
Contacts
CONTACTSara Al-Dalal
CONTACTSara Svensson
PRINCIPAL_INVESTIGATORDr David Morris
Queen Elizabeth II Health Sciences Centre
Outcome results
None listed