QoL, CIs, QALYs, and Individualized Rehabilitation: The Clinical and Practical Benefits of Regularly Assessing the Quality of Life of Adult Cochlear Implant Recipients.

This study aimed to report quality of life (QoL) scores in unilateral cochlear implant (CI) users and to generate guidance for clinicians on using QoL measures to individualize CI counselling and rehabilitation and to increase access to CIs as a mode of rehabilitation. Participants (n = 101) were unilateral CI users with single-sided deafness (SSD; n = 17), asymmetrical hearing loss (AHL; n = 26), or bilateral hearing loss (Uni; n = 58). Generic QoL was assessed via the Health Utilities Index (HUI-3), and disease-specific QoL was assessed via the Speech, Spatial, and Qualities of Hearing scale (SSQ12) and Nijmegen CI Questionnaire (NCIQ) at preimplantation and at 6 and 12 months of CI use. All groups had significantly increased HUI-3 scores at both intervals. The SSD group showed significant benefit on the SSQ12 at visit 3, the AHL group showed significant benefit on the SSQ12 and most NCIQ subdomains at both intervals, and the Uni group showed significant benefit with both tests at both intervals. Unilateral CI recipients demonstrate improved QoL within the first 12 months of device use. Regular assessment with generic and disease-specific questionnaires has the potential to play an important role in personalizing treatment and possibly in increasing access to CI provision.

Implantation of two generations of Bonebridge after mastoid obliteration with bioactive glass S53P4.

PURPOSE: After radical surgery for chronic cholesteatoma (CWD mastoidectomy), patients have the option to have the posterior wall of their external auditory canal surgically reconstructed with S53P4 bioactive glass. The procedure eliminates some of the restrictions related to having a postoperative cavity and extends the options for a hearing prosthesis. If classic reconstruction is not possible and a hearing aid is not used, we suggest use of a Bonebridge implant. METHODS: This study describes, over 18 months of follow-up, 16 patients after a two-stage surgical procedure: obliteration of the mastoid cavity with bioactive glass followed by Bonebridge implantation. There were 7 patients who received the first generation implant (BCI 601) and 9 who used the second (BCI 602). Before and after implantation, pure tone audiometry, sound field thresholds, and free-field audiometry were performed. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: During the observation period, no serious complications were found. The study demonstrated the safety and validity of the procedures and confirmed the safety of using S53P4 bioactive glass in otosurgery (antibacterial effect, nonrecurrence of cholesteatoma, and no effect on the inner ear). The audiological benefits expected from using the Bonebridge implant processor were also confirmed. CONCLUSION: It is concluded that, after reconstructing the posterior wall of the external auditory canal with bioactive glass, two-stage implantation of a Bonebridge implant in a typical site is a safe solution for patients who have difficult anatomical conditions following their CWD mastoidectomy.

Using Generic and Disease-Specific Measures to Assess Quality of Life before and after 12 Months of Hearing Implant Use: A Prospective, Longitudinal, Multicenter, Observational Clinical Study.

The primary objectives of this study were to evaluate the effect of hearing implant (HI) use on quality of life (QoL) and to determine which QoL measure(s) quantify QoL with greater sensitivity in users of different types of HIs. Participants were adult cochlear implant (CI), active middle ear implant (VIBRANT SOUNDBRIDGE (VSB)), or active transcutaneous bone conduction implant (the BONEBRIDGE (BB)) recipients. Generic QoL and disease-specific QoL were assessed at three intervals: pre-activation, 6 months of device use, and 12 months of device use. 169 participants completed the study (110 CI, 18VSB, and 41BB). CI users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. On some device-specific measures, their QoL also significantly increased between 6 and 12 m device use. VSB users' QoL significantly increased between all tested intervals with the disease-specific measure but not the generic measure. BB users' QoL significantly increased from 0-6 m device use on both the generic- and the disease-specific measures. In sum, HI users experienced significant postoperative increases in QoL within their first 12 m of device use, especially when disease-specific measures were used. Disease-specific QoL measures appeared to be more sensitive than their generic counterparts.

Evaluation of the Bonebridge BCI 602 active bone conductive implant in adults: efficacy and stability of audiological, surgical, and functional outcomes.

PURPOSE: (1) To assess the effectiveness and safety of a bone-conduction implant, the Bonebridge BCI 602, in adults with conductive or mixed hearing loss. (2) To investigate whether the Bonebridge BCI 602 is at least as effective as the Bonebridge BCI 601 in such patients. METHODS: The study group included 42 adults who had either conductive or mixed hearing loss. All patients underwent Bonebridge BCI 602 implant surgery. Before and after implantation, pure-tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed. Word recognition scores were evaluated using the Polish Monosyllabic Word Test. Speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. Subjective assessment of benefits was done using the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: The APHAB questionnaire showed that difficulties in hearing decreased after BCI 602 implantation. Both word recognition in quiet and speech reception threshold in noise were significantly better after BCI 602 implantation and remained stable for at least 12 months. A significant advantage of the device is a reduced time for surgery while maintaining safety. In this study, the mean time for BCI 602 implantation was 28.3 min ± 9.4. CONCLUSIONS: The second-generation Bonebridge BCI 602 implant is an effective hearing rehabilitation device for patients with conductive or mixed hearing loss. Patient satisfaction and audiological results confirm its efficacy and safety. Its new shape and dimensions allow it to be used in patients previously excluded due to insufficient or difficult anatomical conditions. The new BCI 602 implant is as effective as its predecessor, the BCI 601.

The Bonebridge BCI 602 Active Transcutaneous Bone Conduction Implant in Children: Objective and Subjective Benefits.

BACKGROUND: the Bonebridge hearing implant is an active transcutaneous bone conduction implant suitable for various types of hearing loss. It was first launched in 2012 as the BCI 601, with a newer internal part (BCI 602) released in 2019. With the new size and shape, the BCI 602 can be used in patients previously excluded due to insufficient anatomical conditions, especially in patients with congenital defects of the outer and middle ear. OBJECTIVES: the purpose of this study is to evaluate the objective and subjective benefits of the new Bonebridge BCI 602 in children who have hearing impairment due to conductive or mixed hearing loss. Safety and effectiveness of the device was assessed. METHODS: the study group included 22 children aged 8-18 years (mean age 14.7 years) who had either conductive or mixed hearing loss. All patients were implanted unilaterally with the new Bonebridge BCI 602 implant. Pure tone audiometry, speech recognition tests (in quiet and noise), and free-field audiometry were performed before and after implantation. Word recognition scores were evaluated using the Demenko and Pruszewicz Polish Monosyllabic Word Test, and speech reception thresholds in noise were assessed using the Polish Sentence Matrix Test. The subjective assessment of benefits was carried outusing the APHAB (Abbreviated Profile of Hearing Aid Benefit) questionnaire. RESULTS: after implantation of the Bonebridge BCI 602 all patients showed a statistically significant improvement in hearing and speech understanding. The mean word recognition score (WRS) changed from 12.1% before implantation to 87.3% after 6 months. Mean speech reception threshold (SRT) before implantation was +4.79 dB SNR and improved to -1.29 dB SNR after 6 months. All patients showed stable postoperative results. The APHAB questionnaire showed that difficulties in hearing decreased after implantation, with a statistically significant improvement in global score. Pre-operative scores (M = 35.7) were significantly worse than post-operative scores at 6 months (M = 25.7). CONCLUSIONS: the present study confirms that the Bonebridge BCI 602 is an innovative and effective solution, especially for patients with conductive and mixed hearing loss due to anatomical ear defects. The Bonebridge BCI 602 system provides valuable and stable audiological and surgical benefits. Subjective assessment also confirms the effectiveness of the BCI 602. The BCI 602 offers the same amplification as the BCI601, but with a smaller size. The smaller dimensions make it an effective treatment option for a wider group of patients, especially children with congenital defects of the outer and middle ear.

Mastoid Obliteration with S53P4 Bioactive Glass Can Make Bonebridge Implantation Feasible: A Case Report.

BACKGROUND Obliteration of the mastoid cavity with S53P4 bioactive glass is becoming a popular method of treatment, allowing most of the problems with the postoperative cavity to be eliminated. In the case of a hearing aid, reconstruction of the posterior wall of the auditory canal is an extremely beneficial procedure and, in the case of the Bonebridge implant, is necessary. After reconstruction, the FMT transducer is covered by bone and bioactive glass and has no contact with the postoperative cavity. The aim of this article is to present a case report. CASE REPORT A 41-year-old male patient with a history of bilateral otitis media with cholesteatoma since childhood had undergone many ear operations since 2001, including radical modified operations and postoperative revisions. There had been ossiculoplasty using own materials and a Kurz TORP prosthesis which gave a short-term hearing improvement for 3 months. The patient underwent tests for implantable devices, which showed a potential significant improvement in hearing and understanding speech. The patient met the audiological criteria qualifying him for the use of an implantable bone conduction device. However, a CT scan of the temporal bone showed that the Bonebridge implant could not be implanted due to insufficient mastoid volume. In order to safely implant the Bonebridge device, it was necessary to first rebuild the posterior wall of the left ear canal. The absolute condition was no inflammation of the ear or leaks for several months. CONCLUSIONS The two-stage surgical procedure as described in this case report can allow the Bonebridge implant to be used in a wider group of patients with previous anatomical limitations.

Speech Perception Changes in the Acoustically Aided, Nonimplanted Ear after Cochlear Implantation: A Multicenter Study.

In recent years there has been an increasing percentage of cochlear implant (CI) users who have usable residual hearing in the contralateral, nonimplanted ear, typically aided by acoustic amplification. This raises the issue of the extent to which the signal presented through the cochlear implant may influence how listeners process information in the acoustically stimulated ear. This multicenter retrospective study examined pre- to postoperative changes in speech perception in the nonimplanted ear, the implanted ear, and both together. Results in the latter two conditions showed the expected increases, but speech perception in the nonimplanted ear showed a modest yet meaningful decrease that could not be completely explained by changes in unaided thresholds, hearing aid malfunction, or several other demographic variables. Decreases in speech perception in the nonimplanted ear were more likely in individuals who had better levels of speech perception in the implanted ear, and in those who had better speech perception in the implanted than in the nonimplanted ear. This raises the possibility that, in some cases, bimodal listeners may rely on the higher quality signal provided by the implant and may disregard or even neglect the input provided by the nonimplanted ear.

A Comparative Study of a Novel Adhesive Bone Conduction Device and Conventional Treatment Options for Conductive Hearing Loss.

OBJECTIVE: To compare the audiological performance with the novel adhesive bone conduction hearing device (ADHEAR) to that with a passive bone conduction (BC) implant and to that with a bone conduction device (BCD) on a softband. STUDY DESIGN: Prospective study in an acute setting, single-subject repeated measure in three situations: unaided, with conventional BCDs (passive implant or on softband), and with the ADHEAR. SETTING: Tertiary referral center. PATIENTS: Ten subjects with conductive hearing loss were evaluated with the ADHEAR. Five of these were users of a passive BC implant (Baha Attract with Baha4); five received a BCD (Baha4) on a softband for test purposes. INTERVENTION: Use of non-invasive adhesive bone conduction system for the treatment of conductive hearing loss. MAIN OUTCOME MEASURES: Air and bone conduction thresholds, sound field thresholds, word recognition scores in quiet, and speech recognition thresholds in quiet and noise were assessed. RESULTS: Users of the passive BC implant received comparable hearing benefit with the ADHEAR. The mean aided thresholds in sound field measurements and speech understanding in quiet and noise were similar, when subjects were evaluated either with the ADHEAR or the passive BC implant. The audiological outcomes for the non-implanted group were also comparable between the ADHEAR and the BCD on softband. CONCLUSIONS: Based on our initial data, the ADHEAR seems to be a suitable alternative for patients who need a hearing solution for conductive hearing loss but for medical reasons cannot or do not want to undergo surgery for a passive BC implant.

The Bonebridge in Adults with Mixed and Conductive Hearing Loss: Audiological and Quality of Life Outcomes.

BACKGROUND: Considering that hearing loss has a significant impact on social functioning, everyday activity and a person's emotional state, one of the most important goals of hearing rehabilitation with bone conduction devices is improvement in a patient's quality of life. OBJECTIVES: To measure self-assessed quality of life in patients implanted with the Bonebridge, a bone conduction device. METHOD: Prospective, observational, longitudinal study with one treatment group. Twenty-one patients with mixed or conductive hearing loss were included, and each individual served as its own control. The Abbreviated Profile of Hearing Aid Benefit (APHAB) was used to measure patient-reported quality of life before intervention and at 3 and 6 months after activation of the device. At the same time frames, pure-tone audiometry and speech understanding in quiet and in noise were tested. RESULTS: Hearing-specific quality of life increased significantly after intervention and remained stable up to 6 months. Both word recognition in quiet and speech reception threshold in noise were significantly better after 6 months compared to before surgery. Outcomes of aided speech understanding were independent of initial bone conduction thresholds and equally high (word recognition score >75%) across the device's indication range. CONCLUSIONS: The Bonebridge provides not only significant audiological benefit in both speech understanding in quiet and in noise, but also increases self-perceived quality of life in patients suffering from mixed and conductive hearing loss. Together with a very low rate and minor nature of adverse events, it is the state-of-the-art solution for hearing rehabilitation in patients with mixed or conductive hearing loss up to a bone conduction threshold of 45 dB HL.