10-year Follow-up of a Wide Diameter Bone Anchored Hearing Implant

NCT05058066 | Completed

• 1 other identifier: CAG5173/CBAS5562 10y
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A single centre, open, comparative, parallel group, prospective clinical investigation with a single 10 year follow up visit.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• implant stability

  Implant Stability Quotiënt (ISQ) will be measured at the 10y-visit. The resonance frequency analysis renders an ISQ value ranging from 1 to 100. Measurements shall be performed at the abutment level, as is done in the previous investigations. The highest and lowest ISQ value out of two perpendicular measurements shall be recorded as ISQ High and ISQ low. The measurement should preferably be done by the same Osstell instrument (Osstell, Gothenburg, Sweden) that was used in the previous completed study. SmartPeg Type 43 and 55 shall be used during the measurement (Osstell, Gothenburg, Sweden). The procedures for obtaining ISQ values is described in the manufacturer's instruction that will be handed out to the investigators.

  10 years after implantation

Secondary Outcomes (3)

• implant survival

  10 years after implantation

• soft tissue reaction

  10 years after implantation

• device use

  10 years after surgery

Study Arms (3)

Control implant loaded at 6 weeks post-surgery

ACTIVE COMPARATOR

The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.

Device: Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment

Test implant loaded at 6 weeks post-surgery

EXPERIMENTAL

The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment.

Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment

Test implant loaded at 3 weeks post-surgery

EXPERIMENTAL

The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment.

Device: Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment; Procedure: Early loading

Interventions

Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment DEVICE

The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.

Control implant loaded at 6 weeks post-surgery

Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment DEVICE

The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.

Test implant loaded at 3 weeks post-surgery; Test implant loaded at 6 weeks post-surgery

Early loading PROCEDURE

Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)

Test implant loaded at 3 weeks post-surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in the original trials, patients had to be at least 18 years old.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Cochlear Bone Anchored Solutions: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525EX, Netherlands

Location

Related Publications (1)

• Teunissen EM, Caspers CJI, Vijverberg MA, Mylanus EAM, Hol MKS. Long-Term Follow-up of a Wide-Diameter Bone-Anchored Hearing Implant: 10-Year Experience on Stability, Survival, and Tolerability of an Implant-Abutment Combination. Otol Neurotol. 2023 Jan 1;44(1):40-46. doi: 10.1097/MAO.0000000000003763. Epub 2022 Nov 23.

  PMID: 36417764 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Interventions

Immediate Dental Implant Loading

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: June 24, 2019
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: November 18, 2025

Record last verified: 2021-09

Locations

NL (1)