The bone conduction implant: Clinical results of the first six patients

Abstract

Objective: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin. Design: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device. Study sample: Six patients (age 18–67 years) with mild-to-moderate conductive or mixed hearing loss. Results: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was − 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses. Conclusions: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.

Cytokine expression profile in the bone‐anchored hearing system: 12‐week results from a prospective randomized, controlled study

“…29 New submerged active and passive bone conduction devices that result in intact skin have been introduced in the last few years. 39,40 Even though they seem like good alternatives, they may provide too low amplification for some patients.…”

Electro-acoustic performance of the new bone vibrator Radioear B81: A comparison with the conventional Radioear B71

“…One such application is in a new bone conduction hearing implant system for rehabilitation of patients with mixed or conductive hearing loss, see Eeg-Olofsson et al (2014) and Reinfeldt et al (2014) for more details.…”

Technical design of a new bone conduction implant (BCI) system

“…The surgical method and audiological results of the first patient have been presented by Eeg-Olofsson et al (2014). Audiological and quality of life outcomes with the BCI on the first six patients have been addressed in a clinical study by Reinfeldt et al (2015b). In this study it was shown that the BCI improvement over the unaided condition was statistically significant in all audiometric measures.…”

“…The BCI has been introduced as an alternative to the percutaneous BAHA (Håkansson et al, 2008(Håkansson et al, , 2010Håkansson, 2011;Taghavi et al, 2012b;2012c, Eeg-Olofsson et al;2014;Reinfeldt, 2015b), and the principal design of the BCI system is shown in Figure 1. For the BCI, the skin and subcutaneous tissues are kept intact and no screw attachment to the skull bone is needed.…”

“…It has been concluded that the surgical procedure is regarded as both safe and uncomplicated with minor engagement of the mastoid portion of the temporal bone Reinfeldt et al, 2015b). The BCI transducer is placed in a 4-5 mm deep recess, drilled in the mastoid part of the temporal bone (see Figure 1), and is secured using a thin titanium wire over the casing.…”