Long-Term Stability, Survival, and Tolerability of a Novel Osseointegrated Implant for Bone Conduction Hearing

Abstract

This extensive long-term clinical investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue. The results show that implant loading at 6 weeks is safe.

Three-year experience with the Sophono in children with congenital conductive unilateral hearing loss: tolerability, audiometry, and sound localization compared to a bone-anchored hearing aid

“…It has been demonstrated that 15.2 % of the previous generation percutaneous implants are lost in children and adverse skin reaction were found in 7.8 % of follow-up visits, which is considerably lower in adults [11]. Arguably, in adult patients, skin reactions with percutaneous implants are decreasing to such low values with updated implant designs [12, 13], that no significant difference between soft tissue tolerability between a transcutaneous and percutaneous BCD is to be expected. Furthermore, in children, implant survival is reported to increase with these new implants: implant loss of 3.5 % is reported in children with the wider diameter implants [14].…”

“…This is especially relevant for the application of BCDs in children, as it is reported that children using a BAHA with a previous generation implant experience more complications and implant losses compared to adults [11]. However, it should be noted that, owing to new and wider diameter implant designs, soft tissue reactions of BAHAs have decreased significantly in adults [12, 13], while implant survival increased in the pediatric population [14]. …”

Controlled Clinical Trial on Bone-anchored Hearing Implants and a Surgical Technique With Soft-tissue Preservation

“…When reviewing several frequently used techniques, the linear incision has been shown to be superior in several studies (1)(2)(3). With the linear incision technique, as well as new implant and abutment designs, complications such as implant loss and adverse soft-tissue reactions have decreased to 0 to 4% and 8 to 15% respectively per implant in the adult population (4,5).…”

Clinical results of Cochlear™ BIA300 in children: Experience in two tertiary referral centers

“…This in contrast to the adult population where less soft tissue reactions are noticed with the Cochlear TM BIA300 [6]. Revision surgery appears to be increased in the past few years.…”

“…The six-month report showed higher mean Implant Stability Quotient (ISQ) values and less soft tissue reactions for the new, wider implant compared to the previous generation implant. The good outcomes could be confirmed in other studies [3][4][5] and in long term follow up [6], and resulted in a complete substitution of the previous generation implant in all new BAHI surgeries, not only in adult patients but also in the pediatric population. During the last few years, however, in both centers, we noticed a high incidence of soft tissue reactions, revision surgery and non-users in our pediatric BAHI population.…”