Bone Conduction Hearing Implants Research Articles

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Piezoelectric Bone Conduction Hearing Implant: A Case Series of Audiological, Surgical and Patient-Reported Outcomes

Early Results With the New Active Bone-Conduction Hearing Implant: A Systematic Review and Meta-Analysis.

The bone conduction implant (BCI) 602 is a new transcutaneous BCI with smaller dimensions. However, limited patient numbers restrict the statistical power and generalizability of the current studies. The present systematic review and meta-analysis summarize early audiological and medical outcomes of adult and pediatric patients implanted with the BCI 602 due to mixed or conductive hearing loss. Following the Preferred Reporting items for Systematic Reviews and Meta-analyses guidelines, 108 studies were reviewed, and 6 (5.6%) were included in the meta-analysis. The data on study and patient characteristics, surgical outcomes, and audiological test results were extracted from each article. Meta-analysis employed the fixed-effect and random-effects models to analyze the mean differences (MDs) between pre- and postoperative performances. In total, 116 patients were evaluated, including 64 (55%) adult and 52 (45%) pediatric patients. No intraoperative adverse events were reported, while postoperative complications were reported in 2(3.1%) adult and 2 (3.8%) pediatric patients. Studies consistently showed significant improvements in audiological outcomes, quality of life, and sound localization in the aided condition. In the meta-analysis, we observed a significant difference in the unaided compared to the aided condition in sound field thresholds (n = 112; MD, -27.05 dB; P < 0.01), signal-to-noise ratio (n = 96; MD, -6.35 dB; P < 0.01), and word recognition scores (n = 96; MD, 68.89%; P < 0.01). The implantation of the BCI 602 was associated with minimal surgical complications and excellent audiological outcomes for both the pediatric and the adult cohort. Therefore, our analysis indicates a high level of safety and reliability. Further research should focus on direct comparisons with other BCIs and long-term functional outcomes.

Provision of bone conduction hearing implants in England in adults and children: a review of Hospital Episode Statistics data 2012-2021.

Bone conduction hearing implants are a well-established method of hearing rehabilitation in children and adults. This study aimed to review any changes in provision in England. The total number of bone conduction hearing implantations performed was analysed from 2012 to 2021 utilising Hospital Episode Statistics data for England. The total number of procedures has increased by 58 per cent. One-stage bone conduction hearing implantations in adults accounts for the largest proportion of this increase (93 per cent of the total). The number performed in children has remained stable and accounts for 73 per cent (n = 433) of all two-stage procedures. The data show that bone conduction hearing implant surgery is becoming increasingly popular, particularly in adults. This has correlated with the increase in availability, national recommendations and choice of devices.

Prediction of postoperative speech comprehension with the transcutaneous partially implantable bone conduction hearing system Osia®.

The active transcutaneous, partially implantable osseointegrated bone conduction system Cochlear™ Osia® (Cochlear, Sydney, Australia) has been approved for use in German-speaking countries since April 2021. The Osia is indicated for patients either having conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB HL or less, or having single-sided deafness (SSD). The aim of this retrospective study was to investigate the prediction of postoperative speech recognition with Osia® and to evaluate the speech recognition of patients with MHL and in particular an aided dynamic range of less than 30 dB with Osia®. Between 2017 and 2022, 29adult patients were fitted with the Osia®, 10patients (11ears) with CHL and 19patients (25ears) with MHL. MHL was subdivided into two groups: MHL‑I with four-frequency pure-tone average in BC (BC-4PTA) ≥ 20 dB HL and < 40 dB HL (n = 15patients; 20ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4patients; 5ears). All patients tested abone conduction hearing device on asoftband preoperatively. Speech intelligibility in quiet was assessed preoperatively using the Freiburg monosyllabic test in unaided condition, with the trial BCHD preoperatively and with Osia® postoperatively with Osia®. The maximum word recognition score (mWRS) unaided and the word recognition score (WRS) with the test system at 65 dB SPL were correlated with the postoperative WRS with Osia® at 65 dB SPL. Preoperative prediction of postoperative outcome with Osia® was better using the mWRS than by the WRS at 65 dB SPL with the test device on the softband. Postoperative WRS was most predictive for patients with CHL and less predictable for patients with mixed hearing loss with BC-4PTA ≥ 40 dB HL. For the test device on a softband, the achievable outcome tended to a minimum, with the mWRS tending to predict the realistically achievable outcome. Osia® can be used for the treatment of CHL and MHL within the indication limits. The average preoperative bone conduction hearing threshold also provides an approximate estimate of the postoperative WRS with Osia®, for which the most accurate prediction is obtained using the preoperative mWRS. Prediction accuracy decreases from aBC-4PTA of ≥ 40 dB HL.

A Novel Surgical Technique for BAHA&lt;sup&gt;®&lt;/sup&gt; Attract Implantation

An implantable bone conduction hearing aid is a device that assists hearing by transmitting sound vibration through the bone. It is suitable not only for patients with conductive hearing loss and congenital external aural atresia but also for those with unilateral hearing loss, chronic otitis media, or patients whose normal structure has been destroyed due to previous surgery. In this paper, we introduce a novel surgical technique for an implantable bone conduction hearing aid (BAHA&lt;sup&gt;®&lt;/sup&gt; Attract) that can be performed through minimal incision in a short time under local anesthesia based on accurate anatomical characteristics. We believe this novel technique could provide convenience for patients and surgeons. Additionally, through this technique, we can expect that various types of implantable bone conduction hearing aids that function effectively and safely can be provided for patients.

Prediction of speech understanding with the transcutaneous partially implantable bone conduction hearing system Osia®. German Version

The active transcutaneous, partially implantable osseointegrated bone conduction system Cochlear™ Osia® (Cochlear, Sydney, Australia) has been approved for use in German-speaking countries since April 2021. The Osia is indicated for patients with conductive (CHL) or mixed hearing loss (MHL) with an average bone conduction (BC) hearing loss of 55 dB or less, or with single-sided deafness (SSD). The aim of this retrospective study was to investigate the prediction of postoperative speech recognition with Osia and to evaluate the speech recognition of patients with MHL and an aided dynamic range of less than 30 dB with Osia. Between 2017 and 2022, 29adult patients were fitted with the Osia, 10patients (11ears) with CHL and 19patients (21ears) with MHL. MHL was subdivided into two groups: MHL‑I with four-frequency pure-tone average in BC (BC-4PTA) ≥ 20 dB HL and < 40 dB HL (n = 15patients; 20ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4patients; 5ears). All patients tested abone conduction hearing device on asoftband preoperatively. Speech intelligibility in quiet was assessed preoperatively using the Freiburg monosyllabic test unaided and with the test system and postoperatively with Osia. The maximum monosyllabic score (mEV) unaided and the monosyllabic score with the test system at 65 dB SPL were correlated with the postoperative monosyllabic score with Osia at 65 dB SPL. Preoperative prediction of postoperative outcome with Osia was better using the mEV than the EV at 65 dB SPL with the test device on the softband. Postoperative EV was most predictive for patients with CHL and least predictive for patients with mixed hearing loss with 4PTA BC ≥ 40 dB HL. For the test device at softband, results tended to show the minimum achievable outcome and the mEV tended to predict the realistically achievable outcome. Osia can be used for the treatment of CHL and MHL within the indication limits. The average preoperative bone conduction hearing threshold also provides an approximate estimate of the postoperative EV with Osia, for which the most accurate prediction is obtained using the preoperative mEV. Prediction accuracy decreases from aBC-4PTA of ≥ 40 dB.

Comparison of Active Bone Conduction Hearing Implant Systems in Unilateral and Bilateral Conductive or Mixed Hearing Loss.

To assess and compare binaural benefits and subjective satisfaction of active bone conduction implant (BCI) in patients with bilateral conductive or mixed hearing loss fitted with bilateral BCI and patients with monaural conductive hearing loss fitted with monaural BCI. ITA Matrix test was performed both on patients affected by bilateral conductive or mixed hearing loss fitted with monaural bone conduction hearing implant (Bonebridge, Med-El) before and after implantation of contralateral bone conduction hearing implant and on patients with monaural conductive or mixed hearing loss before and after implantation of monaural BCI. The Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire was administered to both groups of subjects and the results were compared with each other. Patients of group 1 reported a difference of 4.66 dB in the summation setting compared to 0.79 dB of group 2 (p < 0.05). In the squelch setting, group 1 showed a difference of 2.42 dB compared to 1.53 dB of group 2 (p = 0.85). In the head shadow setting, patients of group 1 reported a difference of 7.5 dB, compared to 4.61 dB of group 2 (p = 0.34). As for the APHAB questionnaire, group 1 reported a mean global score difference of 11.10% while group 2 showed a difference of -4.00%. Bilateral BCI in patients affected by bilateral conductive or mixed hearing loss might show more advantages in terms of sound localisation, speech perception in noise and subjective satisfaction if compared to unilateral BCI fitting in patients affected by unilateral conductive hearing impairment. This may be explained by the different individual transcranial attenuation of each subject, which might lead to different outcomes in terms of binaural hearing achievement. On the other hand, patients with unilateral conductive or mixed hearing loss fitted with monaural BCI achieved good results in terms of binaural hearing and for this reason, there is no absolute contraindication to implantation in those patients.

Evaluating the effectiveness of bone conduction hearing implants in rehabilitation of hearing loss.

Implantable hearing devices are indicated for candidates who could not benefit from conventional hearing aids. This study aimed at evaluating their effectiveness in rehabilitation of hearing loss. This study included patients who received bone conduction implants at Tertiary Teaching Hospitals, between December 2018 and November 2020. Data were collected prospectively, and patients were assessed both subjectively using COSI and GHABP questionnaires and objectively using bone conduction and air conduction thresholds, unaided and aided free field speech thresholds. Outcomes of transcutaneous (tBCHD) and percutaneous (pBCHD) bone conduction hearing devices were compared as well as outcomes of unilateral versus bilateral fitting. Postoperative skin complications were recorded and compared. A total of seventy patients were included, thirty-seven of them were implanted with tBCHD and thirty-three with pBCHD. Fifty-five patients were fitted unilaterally compared to 15 bilateral fitting. Preoperative mean of bone conduction (BC) of the overall sample was 23.27 ± 10.91dB, the Air conduction (AC) mean was 69.27 ± 13.75dB. There was significant difference between unaided free field speech score (88.51% ± 7.92) and the aided score (96.79 ± 2.38) with P value = 0.00001. The postoperative assessment using GHABP showed a benefit score mean of 70.95 ± 18.79, patient satisfaction score mean of 78.15 ± 18.39. The disability score improved significantly from a mean of 54.08 ± 15.26 to residual score of only 12.50 ± 10.22 with P < 0.00001 postoperatively. There was significant improvement in all parameters of COSI questionnaire following fitting. Comparison of pBCHDs vs tBCHDs showed a non-significant difference regarding FF speech as well as GHABP parameters. Comparison of the post-operative skin complications was in favor of tBCHDs as (86.5%) of the patients had normal skin postoperatively, compared to 45.5% of patients with pBCHDs devices. Bilateral implantation showed significant improvement of FF speech scores, GHABP satisfaction score, as well as COSI score results. Bone conduction hearing devices are effective solution for rehabilitation of hearing loss. Bilateral fitting yields satisfactory outcomes in suitable candidates. Transcutaneous devices carry significantly lower skin complication rates compared to percutaneous devices.

Patient reported outcome measures in unilateral aural atresia treated using a transcutaneous bone conduction implant (The Cochlear Baha Attract®)

Unilateral aural atresia (UAA) is a congenital condition that is associated with maximal conductive hearing loss. The primary objective of this study was to assess the long-term compliance, complications, and quality of life of pediatric patients with UAA who had transcutaneous bone conduction hearing implants (TCBI). Retrospective consecutive case series at a single centre between 2014 and 2018. Inclusion criteria consisted of UAA patients between 5 to 17 years-old receiving the Cochlear Baha Attract ® device. Demographic and audiologic data was extracted from charts. A prospective telephone survey was done, with patients and their families completing the Glasgow Children's Benefit Inventory (GCBI). Basic descriptive statistics, paired t-tests, and a univariate analysis were completed. Data was successfully collected from all 9 eligible children who received the Cochlear Baha Attract ® device for UAA (100%). The mean follow-up duration was 33 months after TBCI (9-60 months). The mean daily use was 7.7h/day. Pure tone average and mean speech in noise scores were both significantly improved when comparing the unaided condition to the aided condition with TCBI (p<0.001). The majority (89%) of patients had an improvement in GCBI; the median GCBI score was +14.6, indicating overall positive benefit. A linear regression showed no demographic variables were significant for mean daily use or GCBI scores. This preliminary study showed that patients with a TCBI for UAA had high long-term compliance and daily usage rates. TCBI improved the quality of life for the majority of patients and significantly improved hearing measures.

Job satisfaction and quality of life in adult users of bone conduction hearing devices pre-and post-implantation: a 1-year follow-up study

Objective Hearing loss is a growing public health issue that significantly impacts both health-related quality of life and working life. This study investigates how hearing rehabilitation with bone conduction hearing implants impacts health-related quality of life and working life in adults of working age with hearing impairment. Design This longitudinal study used data from Cochlear’s Implant Recipient Observational Study to assess hearing disabilities and job satisfaction in 18–65-year-old recipients of bone conduction hearing implants. Baseline data were collected pre-implantation and patients were followed-up at 12-months post-implantation. Study sample Patient demographics, Health Utilities Index Mark 3, the Speech Spatial and Qualities of Hearing Scale, and self-reported employment data are presented for a sample ranging from 30 to 43 patients, pre-implantation and at 12-months follow-up following implantation with a bone conduction hearing implant. Results Significant improvements in hearing and speech attribute, and overall health-related quality of life were observed between pre-and post-implantation. Overall hearing disability decreased post-implantation and job satisfaction improved. Conclusions Hearing rehabilitation using bone conduction hearing implants are shown to improve health-related quality of life, reduce hearing disability, and improve work performance and satisfaction. Results are representative of healthy and actively working users of bone conduction hearing implants.

Efficient Bone Conduction Hearing Device With a Novel Piezoelectric Transducer Using Skin as an Electrode.

Bone conduction hearing aids are the only non-surgical devices used for conductive hearing loss. However, they are impractical for lifelong use since they require close contact of the transducer with the head skin, causing skin erosion and discomfort. Bone conduction hearing implants and active middle ear implants do not present these issues; however, they require surgery and can sometimes cause issues in the skin surrounding the devices. This study aimed to develop a new bone conduction hearing device that does not exert pressure on the skin or require surgery. Our device modified a piezoelectric element by using the skin of a pinna as one of the two electrodes of a conventional piezoelectric device. We compared the sound transmission of a speaker, a conventional piezoelectric device, or the new device to the Guinea pig cochlea, a physiological sound transducer to the auditory nerve, in normal and air-conductive hearing loss conditions. The novel device transmitted sound to the cochlea even after causing air-conductive hearing loss. Its bone conduction was more efficient than the speaker and the conventional piezoelectric device. We developed a novel type of bone conduction device that efficiently transmits sound to the cochlea by skipping the external auditory canal, tympanic membrane, and middle ear ossicles. This device does not exert pressure on the skin that can result in skin damage, an adverse effect of a conventional bone conduction hearing aid. Our novel hearing device can be used as a substitute for current bone-conduction hearing devices.

A comparative study of audiological outcomes and compliance between the Osia system and other bone conduction hearing implants.

To examine the subjective and objective audiological benefits of the Osia system compared to devices commonly implanted prior to the introduction of this system. Osia recipients with either conductive hearing loss (CHL/MHL) (n = 9) or single-sided deafness (SSD) (n = 8) who underwent surgery from February 2021 to March 2022 were prospectively recruited. The audiological outcomes and usage rate of Osia implantees were compared with those of retrospectively recruited patients implanted with other devices (n = 50). The subjective satisfaction of the Osia implantees was also evaluated through questionnaires. All users of the Osia system were classified as regular users. In the CHL/MHL group, the effective gain of the Osia system (11.1 ± 14.9dB) surpassed that of the Baha and Bonebridge (- 2.7 ± 12.6dB) at 2kHz (p = 0.01, Mann-Whitney U test). Among the devices, the Osia system tended to tolerate the worst bone conduction thresholds, up to the level of 61dB. In the SSD group, the functional gain of Osia at 4kHz (37.5 ± 3.1dB) was higher than that of the Baha and Bonebridge group (26.9 ± 3.0dB) (p = 0.05, Mann-Whitney U test). The Osia system yielded larger audiological gain than the Baha Attract and Bonebridge devices, especially at high frequencies, leading to substantially higher compliance. The Osia system tended to have the strongest tolerance to aggravated bone conduction thresholds among the available transcutaneous bone conduction hearing implants. Therefore, the Osia system could potentially be a good option for CHL/MHL patients with bone conduction thresholds of 50dB HL or more, as well as patients with SSD.

Influence of Bone Conduction Hearing Implantation on Health-Related Quality of Life for Patients with Chronic Otitis Media.

Background: Chronic otitis media is a major public health burden that can result in a disabling hearing loss. Bone conduction hearing implants are an accepted form of hearing rehabilitation in these patients, but evidence supporting their usage typically comes from studies investigating mixed indications. The objective of our study was to examine how these devices impact health-related quality of life and hearing-disability in adult patients suffering from chronic otitis media. Methods: Health Utilities Index-mark III (n = 10) and Speech Spatial and Qualities of Hearing-49 data (n = 6) were extracted for adult patients with chronic otitis media from an international hearing implant registry. Data were compared at baseline and at 12-month post-implantation with a bone conduction hearing implant. Results: Patients demonstrated a clinically relevant mean utility gain of 0.145 following implantation and clinically relevant mean improvement in global speech spatial and qualities of hearing score following implantation. Conclusions: Bone conduction implantation was found to improve hearing and health-related quality of life and reduce hearing disability in a small cohort of patients with chronic otitis media. These data highlight the importance of providing appropriate hearing rehabilitation for individuals with chronic otitis media.

Bone Conduction Hearing Aid

Abstract: The GSM based Soundbite hearing system allows people with hearing disability to hear the sounds via bone conduction to wear an intraoral device and a small microphone in the deaf ear to regain lost hearing. This device consists of GSM modem, PIC16F877A controller and audio amplifier unit. GSM modem will receive incoming calls and automatically answer the call via AT Commands. Then incoming voice signal is converted into low frequency vibration signal that fed through the teeth to cochlea. Unlike implantable bone conduction hearing aids, Sound Bite requires no surgery. Rather, it is the world’s first removable and non-surgical hearing solution to use the well-established principle of bone conduction to imperceptibly transmit sound via the teeth. Custom made for each person, Sound Bite is simple, removable, and totally non-invasive. This paper introduces a novel hearing aid named artificial ultrasonic bone conduction hearing device, which is different from the traditional hearing aid in two sides: 1) sound conduction manner, 2) human perceptive principles. We focus on discussing the structure of the hearing aid and the research of frequency transposition algorithm. In addition, we design algorithm experimental platform and some sample electromechanical transducers.

Modifications to Implanting the OSIA® 2 Bone Conduction Hearing Implant: How I Do it.

This "How I Do It" report describes modifications made to the OSIA bone conduction hearing implant surgery in order to reduce wound complications. Laryngoscope, 132:1850-1854, 2022.

Pediatric morphometric study to guide the optimized implantation of the Osia® 2 implant system

PurposeContinuous technological advances result in the availability of new bone conduction hearing implants, of which their suitability for pediatric patients is of major concern. The CochlearTMOsia® 2 is a new active osseointegrated steady-state implant system that uses digital piezoelectric stimulation to treat hearing loss. The implant in the United States was approved for patients aged 12 years and above, whereas the CE mark is independent of age, the only requirement is body weight of at least 7 kg. Therefore, further clinical studies are required to assess device characteristics in younger patients. The aim of our study was to perform a morphometric study among 5–12-year-old children, and to develop a surgical protocol for Osia 2 system implantation based on these findings.MethodsWe examined retrospectively cranial CT scans of 5–12-year-old patients from our clinical database. We measured the bone and soft-tissue thickness in the region of interest, and the position of the sigmoid sinus. 3D printed temporal bones were also used for planning.ResultsSoft-tissue thickness varied between 3.2 ± 0.5 mm and 3.6 ± 0.6 mm and bone thickness varied between 3.5 ± 1.1 mm and 4.7 ± 0.3 mm. The sigmoid sinus was located 1.3 ± 0.2 cm posterior to the ear canal, and the anterior distance was 4.8 ± 0.9 to 7.1 ± 1.1 mm.ConclusionsOur morphometric studies showed that patients aged 5–12 have different anatomical dimensions compared to adults, but that implantation of the Osia 2 system is feasible in these patients using an altered implant positioning recommended by our data. The Cochlear™ Osia® 2 is, therefore, an option for hearing rehabilitation in younger pediatrics.

A new CochlearTM Osia OSI200 Implantin Spain a case report

&lt;b&gt;Introduction:&lt;/b&gt; Hearing rehabilitation after bilateral conductive deafness for middle ear atresia has different options. Osia OSI200 implant is a new type of implantable bone conduction hearing aid with a new technology that offers both acoustic and aesthetic advantages. &lt;/br&gt;&lt;/br&gt; &lt;b&gt;Case report:&lt;/b&gt; In this paper, we report the first case of a Cochlear OsiaOSI200 implanted in Spain in a 44-year-old patient. He was affected by a bilateral conductive hearing loss due to a congenital bilateral ear malformation. Ear canal atresia and pinna malformation were noted on the left side as well as ossicular chain malformation on the right side. The surgical technique is described and the results are satisfying.

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®

PurposeThe new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017–2021) on audiological outcomes and hearing-related quality of life for the Osia system.MethodsBetween 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2.ResultsMean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17–40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires.ConclusionThe Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.

Patient-Reported Outcomes in Middle Ear and Active Transcutaneous Bone Conduction Hearing Implants.

Objective: This study used questionnaires to examine the patient-reported satisfaction with 2 hearing implant devices to determine the level of overall satisfaction with the devices, which, if any, factors predicted good or poor perceived outcomes, or whether there were any specific aspects of the devices where dissatisfaction was apparent.Methods: A post-treatment questionnaire survey of 39 adult patients who had received a Vibrant Soundbridge (VSB) or Bonebridge (BB) hearing implant, with at least 3 months of follow-up, was conducted using the Glasgow Benefit Inventory (GBI) and Hearing Device Satisfaction Scale (HDSS). Satisfaction scores were compared to pre- and post-operative audiologic outcomes. The correlation between GBI and HDSS scores was also examined.Results: A total of 28 of the 39 patients (72%) responded: 13 with a BB and 15 with a VSB at a mean of 13 months after implantation. The overall mean total GBI score was 30, with no significant differences across the groups. The responders generally reported that they were “satisfied” across most domains of the HDSS. In the study, 25 of the 28 responders were largely satisfied with their devices but 3 respondents were not. Two were known non-users, while one used the device but did not gain the benefit expected. It is instructive to note that all of these dissatisfied recipients were close to the manufacturer recommended limits for implantation of their respective devices at the time of surgery.

Long-Term, Multicenter Results With the First Transcutaneous Bone Conduction Implant.

Investigation of long-term safety and performance of an active, transcutaneous bone conduction implant in adults and children up to 36 months post-implantation. Prospective, single-subject repeated-measures design. Otolaryngology departments of eight German and Austrian hospitals.∗†‡§||¶#∗∗†† Affiliations listed above that did not participate in the study.‡‡§§||||¶¶. Fifty seven German-speaking patients (49 adults and eight children) suffering from conductive or mixed hearing loss, with an upper bone conduction threshold limit of 45 dB HL at frequencies between 500 and 3000 Hz. Implantation of the Bonebridge transcutaneous bone conduction hearing implant (tBCI). Patients' audiometric pure tone averages (PTA4) (0.5, 1, 2, 4 kHz) thresholds (air conduction, bone conduction, and sound field) and speech perception (word recognition scores [WRS] and speech reception thresholds [SRT50%]) were tested preoperatively and up to 36 months postoperatively. Patients were also monitored for adverse events and administered quality-of-life questionnaires. Speech perception (WRS: pre-op: 17.60%, initial activation [IA]: 74.23%, 3M: 83.65%, 12M: 83.46%, 24M: 84.23%, 36M: 84.42%; SRT50%: pre-op: 65.56 dB SPL, IA: 47.67 dB SPL, 3M: 42.61 dB SPL, 12M: 41.11 dB SPL, 24M: 41.74 dB SPL, 36M: 42.43 dB SPL) and sound field thresholds (pre-op: 57.66 dB HL, IA: 33.82 dB HL, 3M: 29.86 dB HL, 12M: 28.40 dB HL, 24M: 28.22 dB HL, 36M: 28.52 dB HL) improved significantly at all aided postoperative visits. Air and bone conduction thresholds showed no significant changes, confirming preservation of patients' residual unaided hearing. All adverse events were resolved by the end of the study. Safety and performance of the tBCI was demonstrated in children and adults 36 months postoperatively.