Conductive and Sensori-neural Hearing Loss in the Same Ear, Conductive Hearing Loss, Unilateral, Profound Sensori-neural Hearing Loss
Conditions
Keywords
Wide diameter implant, ISQ, Ponto, Bone anchored implant
Brief summary
To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used
Detailed description
Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000 patients worldwide have received this surgical intervention (bone-anchored hearing system), since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its bone-anchored hearing system called Ponto. In just over two years, the Ponto has been successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists in 18 countries worldwide. The Ponto implant has previously been available with a 3.75mm diameter and comes in two lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant contact area and enhance implant stability which can potentially allow loading of the sound processor as early as 3 weeks after surgery. The abutment screw incorporates external threads at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for stability measurements. All Ponto implants have the same universal implant-abutment interface. Therefore, they are fully compatible with existing instruments and abutments. Two new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size of the countersink is 3.80mm. It is marked with a W to separate them from existing drills. All products are CE-marked and cleared for the US market by the FDA. Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be studied will include adverse skin reactions, the feasibility of fitting the sound processor three weeks after surgical implantation, and investigation to see if the type of skin reactions observed following implantation could be related to the demographic data of subjects or the type of surgical technique used. Study Design This study is a prospective, multicenter study of subjects' demographic and implant data. Subjects will be enrolled at two US sites. Subject Population Twenty adult subjects 18 years or older will be included in the study from each participating partner site.
Interventions
DEVICEWide diameter bone anchored implant
4.5 mm wide diameter bone anchored implant
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* conductive, mixed or single sided deafness * 18 years of age or older
Exclusion criteria
* younger than 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Holger's Scale | 1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months | Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery |
| Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months | Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Wide Diameter Bone Anchored Implant Intervention: Implantation of a wide diameter bone anchored auditory implant either 3 or 4 mm in length, into the skull on the side of the ear where intervention is intended in order to restore hearing. In the case of a conductive or mixed hearing loss, that side is chosen. In patients with unilateral, profound sensori-neural hearing loss the implant is implanted on that side but the sound is transmitted to the side with the normal hearing ear via bone conduction stimulation.
Wide diameter bone anchored implant: 4.5 mm wide diameter bone anchored implant | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Wide Diameter Bone Anchored Implant |
|---|---|
| Abutment length 12 mm | 3 participants |
| Abutment length 6 mm | 20 participants |
| Abutment length 9 mm | 7 participants |
| Age, Continuous | 60.83 years STANDARD_DEVIATION 16.07 |
| BMI | 28.56 kilogram/M^2 STANDARD_DEVIATION 7.09 |
| Diabetes no | 27 participants |
| Diabetes yes | 3 participants |
| Height | 163.79 centimeters STANDARD_DEVIATION 8.89 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
| Smoking status no | 29 participants |
| Smoking status yes | 1 participants |
| Weight | 76.72 kilogram STANDARD_DEVIATION 19.61 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 1 / 30 |
Outcome results
Primary
Holger's Scale
Holger's Scale is a 5 point that ranges from 0 - 4 scale that assesses skin reactions at the implant site where 0 means no reaction and 4 means excessive granulation, skin overgrowth, or scar formation requiring revision surgery
Time frame: 1 week, 3 weeks, 6 weeks, 3 months, 6 months and 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score 0 at 1 week | 29 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 1 at one week | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at one week | 1 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 0 at 3 weeks | 29 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 1 at 3 weeks | 1 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at 3 weeks | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 0 at 6 weeks | 28 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 1 at 6 weeks | 2 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at 6 weeks | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 0 at 3 months | 29 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 1 at 3 months | 1 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at 3 months | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 0 at 6 months | 30 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 1 at 6 months | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at 6 months | 0 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 0 at 12 months | 29 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | olger score of 1 at 12 months 1 | 1 participants |
| Wide Diameter Bone Anchored Implant | Holger's Scale | Holger score of 2 at 12 months | 0 participants |
Primary
Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane
Presently, the recommendations to load the sound processor on a bone anchored implant is 3 months (for adults). Using outcome measures, i.e., OSSTELL ISQ ranges from 0 -100 where 0 is least stable and 100 being the most stable.
Time frame: At surgery, 1 week, 3 weeks, 6 weeks, 12 weeks, 6 months and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at surgery | 58.43 units on a scale | Standard Deviation 8.01 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at surgery | 58.58 units on a scale | Standard Deviation 7.42 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at one week | 59.70 units on a scale | Standard Deviation 7.03 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at one week | 59.77 units on a scale | Standard Deviation 7.88 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at 3 weeks | 60.53 units on a scale | Standard Deviation 7.14 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at 3 weeks | 60.30 units on a scale | Standard Deviation 7.78 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at 6 weeks | 61.28 units on a scale | Standard Deviation 5.81 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at 6 weeks | 61.02 units on a scale | Standard Deviation 6.56 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at 12 weeks | 61.97 units on a scale | Standard Deviation 5.91 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at 12 weeks | 62.00 units on a scale | Standard Deviation 6.07 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at 6 month | 63.62 units on a scale | Standard Deviation 5.26 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at 6 months | 63.27 units on a scale | Standard Deviation 5.48 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ vertical at 12 months | 63.73 units on a scale | Standard Deviation 5.31 |
| Wide Diameter Bone Anchored Implant | Implant Stability as Measured by the Osstell Implant Stability Quotient in the Vertical and Horizontal Plane | ISQ horizontal at 12 months | 63.62 units on a scale | Standard Deviation 5.26 |