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Certain patients with conductive or mixed hearing loss can benefit from bone-conduction hearing devices or active middle ear implants. Available devices differ in coupling site, energy transfer from the sound processor to the implant, and the active or passive actuator technology. The audiological benefit of those devices depends on the maximum sta...
Contexts in source publication
Context 1
... radio frequency electromagnetic link to the sound processor. The implant decodes the acoustic information that is encoded in the electromagnetically transmitted signal so that electromechanical or piezoelectric actuators can generate vibrations. The specific, currently available devices for the respective energy transmission pathway are shown in Fig. 2 (bottom ...
Context 2
... the actuator is connected to the skin (ADHEAR [MED-EL, Innsbruck, Austria]), the reference equivalent threshold force levels, (RETFL ( DIN EN ISO 389-3, 2016 )) and correction values for the skin mediated attenuation ( Gründer et al., 2008 ) were used to convert maximum force output levels to hearing levels. For boneanchored hearing systems, up to 10 dB better thresholds as compared with the RETFL could be observed ( Carlsson et al., 1995 ) and used as conversion levels for those implants (RETFL dBC ). ...
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Objective
Transcutaneous bone anchored hearing devices (BAHDs) were introduced in an effort to avoid potential complications associated with the abutment of percutaneous BAHDs. Transcutaneous BAHDs can be active or passive. While studies have demonstrated good outcomes with both, a direct comparison of audiological and clinical outcomes of these de...
The current global pandemic caused by coronavirus has uncovered multiple symptoms, including sudden hearing loss in either one or both ears, with different outcomes. We present a 68-year-old female with sudden onset bilateral hearing loss, fever, generalized body weakness, and gastrointestinal disturbances. She tested positive for severe acute resp...
Background:
Spatial hearing is a critical feature in daily life. However, there is quite a range in hearing loss patients regarding the effect of bone conduction device on localization performance.
Objectives:
To analyze the localization performance in patients with bilateral conductive or mixed hearing loss fitted with one Baha® Attract system....
Active middle ear implants (AMEI) are implantable options for patients with sensorineural, conductive, or mixed hearing loss who are not good candidates for hearing aids. The aim of this study was to compare audiological, surgical, quality of life, and sound quality outcomes in adults <60 and ≥60 years receiving an AMEI. Twenty adult patients who u...
Background
Universal Newborn Hearing Screening (UNHS) attempts to identify children with a permanent, bilateral, moderate or greater hearing loss at birth. However, children who are referred from UNHS programs may have conductive hearing loss (CHL), sensorineural, or mixed hearing loss. The aim of this review was to investigate the prevalence, sub-...
Citations
... In addition, besides the MO the definition of evidence based indication criteria requires the necessary dynamic range for sufficient speech intelligibility. However, the needed audible dynamic range to understand speech, which is commonly estimated to be approximately 30 to 35 dB (Carlsson and Håkansson 1997;Rahne and Plontke 2022), may also depend on other factors such as the actual fitting rule and will be treated in detail in an accompanying paper . ...
Objective:
The frequency specific maximum output (MO) of active middle ear implants is the most crucial parameter for speech intelligibility. We determined individual MO from clinical routine data in round window (RW) coupling of the Vibrant Soundbridge (VSB).
Design:
Monocentric, retrospective analysis.
Study sample:
68 ears implanted with the VSB at the RW were analysed. Using bone conduction and direct threshold, MO was determined for combinations of implants (VORP502, VORP503) and processors (Samba, Amadé). Coupling modes were: (A) without coupler (N = 28), (B) spherical coupler (N = 19), (C) soft coupler (N = 10) or (D) custom-made "Hannover coupler" (N = 11).
Results:
The MO frequency dependence was similar for coupling types (A-D) with a maximum at 1.5 kHz. No differences between groups were observed, although the average MO of the soft coupler was 10 dB lower. The average MO (0.5, 1.0, 2.0, 4.0 kHz) was (A) 77.6 ± 15.0 dB HL, (B) 81.0 ± 11.1 dB HL, (C) 67.6 ± 17.9 dB HL (C), and (D) 79.6 ± 11.7 dB HL (D).
Conclusion:
The individual MO can be determined from patients' clinical data. It permits in-depth analyses of patient outcomes and definition of evidence-based indication and decision criteria.
... The specific device characteristics of MEI and BCI with respect to the available dynamic range and their effective gain play an important role [23,[29][30][31]. The sensorineural component of HL must fall well within the indication range as defined by the manufacturer [23]. ...
... The sensorineural component of HL must fall well within the indication range as defined by the manufacturer [23]. Since there are various hearing systems and options available [30,31], more studies are needed to define the relationship between the achievable outcome and the preoperative audiometric assessment. To summarise, this topic is a highly challenging one. ...
... B one-anchored hearing aids have proven effective in treating patients with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD) since the late 1970s and early 1980s. 1 They are especially beneficial for individuals with CHL or MHL resulting from congenital ear malformation or multiple prior surgeries, where traditional hearing aids are not suitable. 2 Initially, bone conduction implants (BCIs) used a percutaneous approach, with an audio processor connected to a screw (abutment) and an audio transducer through the skin. 2 However, this design posed inherent limitations, including higher rates of revisions due to infections, prompting the exploration of alternative approaches. [3][4][5] The BCIs 601, developed by MED-EL became the first transcutaneous BCI to receive CE-mark approval for adults in 2012 and has been widely utilized in the treatment of CHL, MHL, and SSD. ...
... 2 Initially, bone conduction implants (BCIs) used a percutaneous approach, with an audio processor connected to a screw (abutment) and an audio transducer through the skin. 2 However, this design posed inherent limitations, including higher rates of revisions due to infections, prompting the exploration of alternative approaches. [3][4][5] The BCIs 601, developed by MED-EL became the first transcutaneous BCI to receive CE-mark approval for adults in 2012 and has been widely utilized in the treatment of CHL, MHL, and SSD. ...
... The systematic review and meta-analysis were performed in conjunction with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. 15 Inclusion criteria were defined according to the population, intervention, comparison, outcomes, study 16 format: (1) subjects of any age, with unilateral or bilateral MHL or CHL; (2) implantation of the BCI 602 active transcutaneous conduction device; (3) comparison of preand postsurgical outcomes; (4) subjective and objective audiological assessment, quality of life, or surgical outcome and complications; and (5) retrospective and prospective cohort studies, randomized control trials, and case series. Exclusion criteria were non-English language, review papers, case reports of fewer than 5 patients, insufficient data availability, and nonhuman and experimental studies. ...
... B one-anchored hearing aids have proven effective in treating patients with conductive hearing loss (CHL), mixed hearing loss (MHL), or single-sided deafness (SSD) since the late 1970s and early 1980s. 1 They are especially beneficial for individuals with CHL or MHL resulting from congenital ear malformation or multiple prior surgeries, where traditional hearing aids are not suitable. 2 Initially, bone conduction implants (BCIs) used a percutaneous approach, with an audio processor connected to a screw (abutment) and an audio transducer through the skin. 2 However, this design posed inherent limitations, including higher rates of revisions due to infections, prompting the exploration of alternative approaches. [3][4][5] The BCIs 601, developed by MED-EL became the first transcutaneous BCI to receive CE-mark approval for adults in 2012 and has been widely utilized in the treatment of CHL, MHL, and SSD. ...
... 2 Initially, bone conduction implants (BCIs) used a percutaneous approach, with an audio processor connected to a screw (abutment) and an audio transducer through the skin. 2 However, this design posed inherent limitations, including higher rates of revisions due to infections, prompting the exploration of alternative approaches. [3][4][5] The BCIs 601, developed by MED-EL became the first transcutaneous BCI to receive CE-mark approval for adults in 2012 and has been widely utilized in the treatment of CHL, MHL, and SSD. ...
... The systematic review and meta-analysis were performed in conjunction with the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines. 15 Inclusion criteria were defined according to the population, intervention, comparison, outcomes, study 16 format: (1) subjects of any age, with unilateral or bilateral MHL or CHL; (2) implantation of the BCI 602 active transcutaneous conduction device; (3) comparison of preand postsurgical outcomes; (4) subjective and objective audiological assessment, quality of life, or surgical outcome and complications; and (5) retrospective and prospective cohort studies, randomized control trials, and case series. Exclusion criteria were non-English language, review papers, case reports of fewer than 5 patients, insufficient data availability, and nonhuman and experimental studies. ...
Objective
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.
Data Source
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.
Review Method
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.
Results
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).
Conclusion
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.
... After collecting data from the previous process, we will now proceed to analyze all the gathered information [40]. This opens the way for the inclusion and exclusion criteria for information from the Scopus database, focusing only on document types such as reviews, scientific articles, conference papers, and books [41], as they provide the necessary information for this research [42]. Thanks to this process, we can enter a critical stage, ensuring validation in the systematic review [43].To carry out this analysis process, we must consider using Boolean algorithms through logical operators to broaden the search [44]. ...
... The indication process and the evaluation of the results obtained with transcutaneous and percutaneous systems are widely discussed in the international literature (2,4,8,(10)(11)(12) by demonstrating that both are effective in the auditory rehabilitation of these individuals. Currently, it is known that the advantage of the transcutaneous system is that it allows the skin to remain intact, which minimizes the post-surgical problems observed in the percutaneous, such as irritation, inflammation and infection of the skin, and even the loss of the implant (2,13,14) . ...
Purpose
Longitudinally verify the influence of auditory tonal thresholds obtained with transcutaneous and percutaneous bone-anchored hearing aids on speech perception in individuals with external and/or middle ear malformation and chronic otitis media.
Methods
Observational, retrospective, longitudinal follow-up study of 30 unilateral users of the transcutaneous and percutaneous Baha® system for the collection of secondary data on pure tone thresholds obtained through free field audiometry and sentence recognition threshold in silence and noise in conditions: without the prosthesis; at the time of activation; in the first month of use (post 1); and in the third month (post 2).
Results
There was a significant difference between pure tone thresholds obtained at frequencies of 3 and 4kHz with better results for the percutaneous technique at all evaluation moments. For both systems, better performance was observed in sentence recognition in silence and in noise, with a significant difference in activation (p<0.001), but it remained stable during the other evaluation moments. The percutaneous system showed better benefit in recognizing sentences in noise only on activation (p=0.036), when compared to the transcutaneous system.
Conclusion
The percutaneous system provided better audibility for high frequencies; however, such audibility did not influence sentence recognition in the silent situation for both systems. For the noise situation, better responses were observed in the percutaneous system, however, the difference was not maintained over time.
Keywords:
Bone Conduction; Ear Malformation; Speech Audiometry; Hearing Loss; Hearing Aids
... A indicação pode ser uni ou bilateral, desde que seja observada a simetria entre os limiares obtidos por condução óssea (9) . O processo de indicação e a avaliação dos resultados obtidos com as PAAO transcutânea e percutânea são amplamente discutidos na literatura internacional (2,4,8,(10)(11)(12) , ao demonstrarem que ambas são eficazes na reabilitação auditiva destes indivíduos. Atualmente, sabe-se que a vantagem do sistema transcutâneo é a de permitir que a pele permaneça intacta, o que minimiza os problemas pós-cirúrgicos observados no percutâneo, como irritação, inflamação e infecção da pele e, até mesmo, a perda do implante (2,13,14) . ...
Purpose
Longitudinally verify the influence of auditory tonal thresholds obtained with transcutaneous and percutaneous bone-anchored hearing aids on speech perception in individuals with external and/or middle ear malformation and chronic otitis media.
Methods
Observational, retrospective, longitudinal follow-up study of 30 unilateral users of the transcutaneous and percutaneous Baha® system for the collection of secondary data on pure tone thresholds obtained through free field audiometry and sentence recognition threshold in silence and noise in conditions: without the prosthesis; at the time of activation; in the first month of use (post 1); and in the third month (post 2).
Results
There was a significant difference between pure tone thresholds obtained at frequencies of 3 and 4kHz with better results for the percutaneous technique at all evaluation moments. For both systems, better performance was observed in sentence recognition in silence and in noise, with a significant difference in activation (p<0.001), but it remained stable during the other evaluation moments. The percutaneous system showed better benefit in recognizing sentences in noise only on activation (p=0.036), when compared to the transcutaneous system.
Conclusion
The percutaneous system provided better audibility for high frequencies; however, such audibility did not influence sentence recognition in the silent situation for both systems. For the noise situation, better responses were observed in the percutaneous system, however, the difference was not maintained over time.
Keywords:
Bone Conduction; Ear Malformation; Speech Audiometry; Hearing Loss; Hearing Aids
... These implants operate by directly conveying vibrations to the inner ear through the bone conduction pathway. However, particularly in patients with mixed hearing loss, their use is restricted by the maximum output level and transmission efficiency, which limits the dynamic range available for acoustic stimulation (4,5). ...
Introduction
An optimal placement of bone conduction implants can provide more efficient mechanical transmission to the cochlea if placed in regions with greater bone column density. The aim of this study was to test this hypothesis and to determine the clinical potential of preoperative bone column density assessment for optimal implant placement.
Methods
Five complete cadaver heads were scanned with quantitative computed tomography imaging to create topographic maps of bone density based on the column density index (CODI). Laser Doppler vibrometry was used to measure cochlear promontory acceleration under bone conduction stimulation in different locations on the temporal bone, using a bone-anchored hearing aid transducer at frequencies ranging from 355 Hz to 10 kHz.
Results
We found a statistically significant association between CODI levels and the accelerance of the cochlear promontory throughout the frequency spectrum, with an average increase of 0.6 dB per unit of CODI. The distance between the transducer and the cochlear promontory had no statistically significant effect on the overall spectrum.
Discussion
We highlight the importance of bone column density in relation to the mechanical transmission efficiency of bone conduction implants. It may be worthwhile to consider column density in preoperative planning in clinical practice.
... Thus, in addition to the medical indication, the assessment of the audiological indication based on the BC hearing threshold is of central importance [13]. Another criterion for the indication and for estimating the expected success of the fitting is the maximum power output (MPO) of the BC system [13,14]. The MPO represents the frequency-dependent course of the maximum power as a sound pressure level (dB SPL) or force level (dB FL). ...
... Consideration of a b Fig. 3 8 Relationships between pre-and postoperative word recognition score. a Word recognition score (WRS) achieved with the Osia above the maximum word recognition score (mWRS [14], tended to achieve a WRS with Osia that differed only slightly from the the current cochlear implant indication of a WRS ≤ 60% WRS at 65 dB SPL in best aided condition (current German CI guideline) [18]. Thus, the indication limit of a maximum 55 dB HL with a BC-PTA4 should be considered individually and critically. ...
Background
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).
Objectives
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®.
Materials and methods
Between 2017 and 2022, 29 adult patients were fitted with the Osia®, 10 patients (11 ears) with CHL and 19 patients (25 ears) 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 = 15 patients; 20 ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL ( n = 4 patients; 5 ears). All patients tested a bone conduction hearing device on a softband 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.
Results
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.
Conclusion
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 a BC-4PTA of ≥ 40 dB HL.
... Ein weiteres Kriterium für die Indikationsstellung bzw. zur Abschätzung des zu erwarten-den Versorgungserfolgs ist der maximale Ausgangspegel ("maximum power output", MPO) des Knochenleitungssystems [13,14]. Der MPO stellt den frequenzabhängigen Verlauf der Maximalleistung als Schalldruckpegel (dB SPL) oder Kraftpegel (dB FL) dar. ...
... Das postoperative EV der Gruppe komb-SH-II weist mit Werten zwischen 60 und 80 % eine große Spanne auf. Die vorliegenden Ergebnisse zeigen eine Tendenz, dass insbesondere Patienten mit einer PTA4-KL ≥ 40 dB HL, welche somit einen limitierten Dynamikbereich von ≤ 30 dB aufweisen [14], ein EV mit Osia erreichen, welches sich nur wenig von dem maximalen EV der aktuellen Cochleaimplantat(CI)-Indikation von 60 % bei 65 dB SPL [18] ...
Background:
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).
Objectives:
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.
Materials and methods:
Between 2017 and 2022, 29 adult patients were fitted with the Osia, 10 patients (11 ears) with CHL and 19 patients (21 ears) 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 = 15 patients; 20 ears) vs. MHL-II with BC-4PTA ≥ 40 dB HL (n = 4 patients; 5 ears). All patients tested a bone conduction hearing device on a softband 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.
Results:
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.
Conclusion:
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 a BC-4PTA of ≥ 40 dB.
