Single-stage Surgery Using the BI300 Implant

NCT04038216 | Terminated

• 1 other identifier: 2019-5407
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Over the last few decades, the classical two-stage surgical procedure for inserting bone-anchored hearing implants (BAHIs) has been modified in adults into a single-stage procedure. This approach has several advantages since it avoids a second surgical procedure. The single-stage approach is proven to be safe and feasible in adults and is nowadays referred to as the standard surgical technique in adults. Despite favorable outcomes and advantages of the single-stage surgery, most Ear Nose Throat (ENT)-surgeons still perform two-stage surgery when inserting BAHI in the pediatric population. Therefore, the aim of this study is to compare implant loss between single-stage BAHI surgery and two-stage BAHI surgery in children aged 4 to 9 years.

Conditions

Hearing Impaired Children; Hearing Impairment, Conductive

Keywords

Single-stage surgery; Bone conduction devices; Pediatric population; Implant loss

Outcome Measures

Primary Outcomes (1)

• Implant loss

  The number of lost implants

  1 year

Secondary Outcomes (4)

• Soft-tissue status according to Holgers scale

  1 year

• Time to loading

  through study completion, an average of 1 year

• Duration of surgery

  through study completion, an average of 1 year

• Soft-tissue status according to IPS scale

  1 year

Study Arms (2)

Test

In the test group, patients will be scheduled for bone-anchored hearing implant surgery using the single-stage procedure. The implant and abutment will be placed in one surgery.

Procedure: Single-stage surgery

Control

Historical control group, these patients already underwent BAHI insertion using two-stage surgery. The implant and abutment were inserted in two different procedures.

Other: Two-stage surgery

Interventions

Single-stage surgery PROCEDURE

the bone-anchored hearing implant will be inserted in one surgery

Test

Two-stage surgery OTHER

Two-stage surgery has already been performed, data will therefore be retrospectively collected

Control

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients 4 to 9 years old who are planned for treatment with a BAHI (BI300 implant) are considered candidates for the study. They will be approached for participation in the trial after they have chosen a Cochlear sound processor after thorough clinical and audiological testing and counseling. These patients are selected from a tertiary referral center.

You may qualify if:

• Age 4-9 years
• Indication for percutaneous bone-anchored hearing implant surgery with a BI300 implant
• Insertion using the linear incision technique
• Children who underwent implantation of a wide diameter implant using two-stage surgery between 2012 and 2018 at the Radboudumc
• Age 4-9 at the time of surgery
• Linear incision technique was used during surgery

You may not qualify if:

• Inability to show up at all follow-up visits
• Patients undergoing re-implantation
• Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
• Insufficient bone thickness ≤1mm, since conversion to two-stage surgery will be advocated
• Follow-up duration less than 1 year.
• Diseases, syndromes or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus (at moment of implantation)

Sponsors & Collaborators

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

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6500hb, Netherlands

Location

Related Publications (6)

• Saliba I, Froehlich P, Bouhabel S. One-stage vs. two-stage BAHA implantation in a pediatric population. Int J Pediatr Otorhinolaryngol. 2012 Dec;76(12):1814-8. doi: 10.1016/j.ijporl.2012.09.007. Epub 2012 Sep 23.

  PMID: 23010336 BACKGROUND

• Kohan D, Morris LG, Romo T 3rd. Single-stage BAHA implantation in adults and children: is it safe? Otolaryngol Head Neck Surg. 2008 May;138(5):662-6. doi: 10.1016/j.otohns.2007.12.019.

  PMID: 18439475 BACKGROUND

• Ali S, Hadoura L, Carmichael A, Geddes NK. Bone-anchored hearing aid A single-stage procedure in children. Int J Pediatr Otorhinolaryngol. 2009 Aug;73(8):1076-9. doi: 10.1016/j.ijporl.2009.03.028. Epub 2009 May 26.

  PMID: 19473711 BACKGROUND

• Marsella P, Scorpecci A, D'Eredita R, Della Volpe A, Malerba P. Stability of osseointegrated bone conduction systems in children: a pilot study. Otol Neurotol. 2012 Jul;33(5):797-803. doi: 10.1097/MAO.0b013e318255dd73.

  PMID: 22643446 BACKGROUND

• de Wolf MJ, Hol MK, Huygen PL, Mylanus EA, Cremers CW. Nijmegen results with application of a bone-anchored hearing aid in children: simplified surgical technique. Ann Otol Rhinol Laryngol. 2008 Nov;117(11):805-14. doi: 10.1177/000348940811701103.

  PMID: 19102125 BACKGROUND

• Mazita A, Fazlina WH, Abdullah A, Goh BS, Saim L. Hearing rehabilitation in congenital canal atresia. Singapore Med J. 2009 Nov;50(11):1072-6.

  PMID: 19960162 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Study Officials

• Hol, dr

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: July 30, 2019
• Study Start: September 1, 2019
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)