HEARRING Counselling Tool

HEARRING Counselling Tool - Surv

Title
HEARRING Counselling tool for hearing loss treatment

Aim
This tool, designed by experts for experts, aims to facilitate the counselling process for patients by providing benefits and drawbacks of a selected treatment option in a standardized way.
It is not designed to counsel towards a choice of treatment. It will be applied only after an implant/treatment option is already decided on.

Why is it useful?
- designed by the HEARRING group which is comprised of world-renowned experts
- the tool is evidence-based (more than 120 publication)
- pictures and animations are offered in order to support the counselling process

Your task
May we ask you to please go through this survey step by step and give us feedback about the content after the following criteria:
- Are the lists of statements covering all aspects of a successful counselling process (please take our suggestions on the right into consideration)? May statements be removed or added?
- Do you agree with the suggested publications to support each statement? Please add any paper that comes to your mind!
- Are the citations and consents representing the underlying statement?

Thank you for your contribution.

Untitled 1

BONE CONDUCTION | Non-implantable

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
No surgical procedure	"It provides an excellent alternative in the treatment (…) without the possible complications and costs of a surgical intervention." (Osborne et al. 2019) More: Westerkull 2018	H
Non-invasive	"As all these systems employ passive or skin-drive BC to improve hearing, the vibrations emitted by the BC transducer have to be relayed through the intact skin to the bone." (Skarzynski et al. 2019)	H
Reversable	As non-implantable devices are always attached to the skin via an external fixation, the device can be taken off whenever necessary or wanted. (consensus) More: Neumann et al. 2019, Mertens et al. 2017, Osborne et al. 2019	H
Audilogical benefit/good hearing outcomes	"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." (Skarzynski et al. 2019) "ADHEAR delivers the same audiological benefit like SoundArc in CHL-users and that without any pressure onto the skull." (Gawliczek et al. 2018) "The mean unaided free field hearing threshold of 50 dB HL(...), improved significantly by 22 dB (13.0-29.9) with the ADHEAR and by 23 dB (13.6-32.9) with the BCHA (p < 0.001). Furthermore, the mean unaided speech recognition threshold (SRT) in quiet improved significantly by 19 dB (10.3-28.1) with the ADHEAR and by 21 dB (12.6-29.4) with the BCHA (p < 0.001). For both audiological tests, there were no significant differences between the ADHEAR and the BCHA." (Favoreel et al. 2020) More: Gavilán et al. 2019, Zernotti et al. 2019, Brill et al. 2019, Dahm et al. 2019, Weiss et al. 2019, Neumann et al. 2019, Urik et al. 2019, Dahm et al. 2018	H
MRI compatible	The simple removal of the whole device is the only necessity to undergo a MRI. (HEARRING consensus)	H
No age limitation	As non implantable devices work via a non invasive concept and are straightforward to use, every group of age can benefit from this treatment option. (consensus) More: Verhagen et al. 2008	A
Tryout possible/testing	"The use of BAHA on a softband (elastic fabric) or headband (diadem type) (…) is the gold standard for preoperative assessment." (Reinfeldt et al. 2015) "The headband or test rod, although crude in many ways, still offers an easy, fast and objective way of assessing bone conduction capacity which allows the patient to directly experience bone conducted sound, and so helps in decision making for him/her." (Hagr et al. 2007) "This adhesive hearing system is a safe and effective device to treat transient conductive hearing loss and may considerably improve treatment for patients even with short-term hearing loss." (Weiss et al. 2019) "It is possible to predict the hearing outcomes of an active BC implant through the pre op use of a non implantable device" (indirect citation by Canale et al. 2019) More: Canale et al. 2019, Spielman et al.2018	A X	Rewording suggested - "try out possible / easy testing"

Comment:

Drawbacks

Drawbacks

Statement	Literature	Notes
Limited gain	"However, due to dampening of energy by skin and soft tissue, especially in the high frequencies, the application of these devices has limitations. In the frequency range of 1 to 4 kHz this has been reported to be as much as 20 dB compared with percutaneous or direct-drive BC implants." (Dahm et al. 2018)	H
Skin irritation (sticker)/skin issues	"In conclusion, this new, adhesive bone conduction hearing aid has a high patient satisfaction rate while causing no skin irritation or pain." (Dahm et al. 2018) "Bone conduction hearing devices integrated in softbands (BCDSs) are frequently not well accepted by children with conductive hearing loss due to pressure on the head, sweating, or cosmetic stigma." (Neumann et al. 2019) More: Verhagen et al. 2008, Osborne et al. 2019, Canale et al. 2019, Reinfeldt 2015	H X	Rewording suggested - "skin issues"
SSD limited gain	"Observation in clinical practice shows that, still, the majority of BCD trial experiences in the general SSD population are negative." (Mertens et al. 2018)	H
Funding costs	n/a	H X	Suggestion to remove it / country specific
Microphone orientation	"For the adhesive hearing system on the other hand, improved localization skills were observed when using the omnidirectional microphone." (Mertens et al. 2018)	H X	Suggestion to remove it / product specific
Limited retention (weather)	"Adapter adhesion was sufficient for most of the subjects in our study but varied between one and seven days among participants. Excessive handling of the adapter or rubbing against car seats, armrests, hats etc. as well as variations in mastoid shape, skin type, sweating, or a combination of these factors could cause the observed differences." (Neumann et al. 2019)	H X	Suggestion to remove it / product specific

Comment:

Title

BONE CONDUCTION | Active transcutaneous

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

*Statement*	*Literature*	*Notes*
Intact skin	"Advantages especially in children include the lack of a skin-penetrating abutment, which substantially removes the need for medical follow-up, the external device is compact, simple to use and is considerably better cosmetically." (Kulasegarah et al. 2018) "The main advantage of transcutaneous devices, both active and passive, is that they keep the skin intact." (Lasaletta et al. 2016)	H
Audiological improvement / hearing outcomes	"All outcomes reported and summarized here reflect beneficial audiological performance and high patient satisfaction, accompanied with a low complications rate." (Magele et al. 2019) "So, when comparing pre-surgical results of BahaV R5 Power with softband to postoperative surgical procedures with the OsiaTM system at 2months after activation, the average functional gain for all frequencies was statistically higher (p<.05) for OsiaTM System (36.88dB) than for Baha 5 Power (30,57dB)" (Goycoolea et al. 2020) "Statistically significant improvements in audibility, speech-understanding, speech-recognition and quality-of-sound in noise and quiet were found for the OsiaTM compared to preoperative unaided hearing and aided hearing with the Baha 5 PowerV R Sound Processor on a softband." (Goycoolea et al. 2020) More: Maier et al. 2013, Skarzynski et al. 2019, Zernotti et al. 2016, 2019, Fan et al. 2017, 2019, Der et al. 2018, Ihler et al. 2016, Gerdes et al. 2016, Sprinzl et al. 2013, Baumgartner et al. 2016, Lasaletta et al. 2016, Rader et al. 2018	H
Better high frequency hearing (compared to pt)	"The active vibration system provided improvement at low and high frequencies. (…) In the case of the passive device BAHA Attract, the performance drops gradually above 3000Hz because of the soft tissue attenuation of the externally generated vibration (...)" (Goycoolea et al. 2020) A comparative study of active and passive devices by Zernotti et al. also showed that active devices had a better performance at medium and high frequencies. (indirect citation / Zernotti et al. 2015)	H
Best option for malformations	"In our experience, bone conduction thresholds in children with a malformation (e.g., atresia) are normal and remain stable after the implantation of a BCI." (Schilde et al. 2017)	H
Less skin pressure / no skin pressure	"Since the external processor does not include a vibrator, the weight is quite low, which reduces the risk of the external device falling off, while increasing wearing comfort since less magnetic force is required for retention." (Westerkull 2018) More: Lasaletta et al. 2016	H
Acute immediate benefit	"Moreover, the fast activation of the implant system enables the recipient of the system to benefit in a short time frame postoperatively from the intervention." (Sprinzl et al. 2016)	H X	Suggestion to delete it / not given for OSIA - osseointegration - product specific
Local anaesthesia	"Implantation of the Bonebridge with local or general anesthesia is a safe and feasible procedure, with audiometric results that can come close with the ones provided by BAHD users." (Manrique et al. 2014)	H X	No data for OSIA?
Simple surgery	"All patients whose implantable part of the device was fixed to the skull bone and additionally compressed underlying dura and/or sinus for several millimeters (range 2 - 5 mm) had good hearing outcomes." (Vyskocil et al. 2016)	H X	Product specific? OSIA ?
MRI conditional	"MRI of the brain can be performed in patients with active transcutaneous bone conduction implants (BB) at 1.5 T without sacrificing diagnostic imaging quality, provided that special MRI artifact reduction sequences, like the SEMAC-VAT metal artifact reduction sequences optimized in Bern, are acquired." (Wimmer et al. 2019)	A
All day wearing comfort	"All patients use their devices all day during their daily activities."(Goycoolea et al. 2020) Baumgartner et al. (2016) determined a mean of 11.2 hours of wearing time (indirect citation / Baumgartner et al. 2016)) Zernotti et al. (2016) concluded that BONEBRIDGE users (8-12 h/d) showed a significantly longer wearing time of the device compared to SOPHONO Alpha recipients (7-10 h/d) (indirect citation / Zernotti et al. 2016)	A
Subjective benefit	"The SSQ-12 was completed at all intervals (pre, post-2 and post-6months). Statistically significant improvements (p<.05) were observed in the SSQ-12 Speech and Qualities scales when comparing pre to 2months and pre to 6months conditions, which may indicate that the reported benefit can be even greater after one year of use." (Goycoolea et al. 2020) Improvement of subjective benefit in several different kind of questionnaires significantly shown (indirect citation / Magele et al. 2019) More: Sprinzl 2013, Baumgartner 2016, Skarzynski 2019	A

Comment:

Drawbacks

Drawbacks

Statement	Literature	Notes
Larger MRI artefact	"Magnetic resonance imaging (MRI) is often limited in patients with auditory implants because of the presence of metallic components and magnets ... The sequence for metal artifact reduction optimized in Bern enables MRI at 1.5 T in patients with active transcutaneous bone conduction implants without sacrificing diagnostic imaging quality." (Wimmer et al. 2019)	H
Connectivity	Depending on the manufacturer there are different options of how to connect the audioprocessor to bluetooth devices. (HEARRING consensus)	H X	Suggestion to delete it / product specific / marketing related
Longer surgery than with Passive transcut.	"The complexity of the surgery of these transcutaneous implants is substantially greater than that of percutaneous implants." (Gerdes et al. 2016)	H X
Anatomical limitations	Every implant, that is fixated onto or into the temporal bone and lies subcuatneously, has limitations regarding patient`s anatomy. (HEARRING consensus)	H X
Helmets	It is required to counsell the recipient about the importance of exact placement of the coil-section of the implant, due to the fact that the audioprocessor might be in the way of helmets, hats or other things. (consensus of HEARRING)	H
Skin thickness	Audioprocessors, which are held over the implant via magnetic attraction, tolerate only a maximum of skin thickness depending on the product in order to attach properly. (consensus of HEARRING)	H X	Suggestion to delete it / also for all the other categories given

Comment:

Title

BONE CONDUCTION | Passive transcutaneous

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
Intact skin	"(…) the passive transcutaneous skin-drive BCDs contain implanted magnet(s)." (Reinfeldt et al. 2015) "The skin condition remains intact in all the cases." (Dolhen et al. 2020) "The processed sound in the audio processor produces the vibration of the external magnet, which vibrates the implanted magnet by inducing a magnetic field through the intact skin." (Gavillan et al. 2015) More: Cooper 2017	H
Quick surgery	"The standard surgical technique for BAHA Attract is a multi-tools time-consuming process, which requires a large cutaneous incision." (Dolhen et al. 2020)	H
MRI conditional	Depending on the product, patients can undergo MRI when following the manufactureres protocol.	H

Comment:

Drawbacks

Drawbacks

Statement	Literature	Notes
Weak audiological amplification	"Overall, the pTCBIs demonstrated good audiological outcomes with a mean PTA gain of 28.4 2.1 dB and SRT gain of 32.9 3.9 dB." (Cooper et al. 2017) "Given the lower thickness of the internal magnet, the Sophono™ system might be more suitable for younger children, whereas BAHA offered better functional results. Both systems can be considered valid and safe options for the functional rehabilitation of conductive hearing loss in children, provided that precautions are observed, such as a gradual use of the device and use of the least powerful magnets in the first months after the activation." (Giannantonio et al. 2018) "BB implant showing a better performance at medium and high frequencies. Furthermore, the BB, as an active implant, showed higher functional gain and increased time of use, when compared to the SP, a passive system." (Zernotti et al. 2016)	H
Pain / pressure	"A typical pressure is at least 2 N which most often gives discomfort and problems in the skin and subcutaneous tissues between the transducer and the bone if used long-term. The high static pressure can also give tension headaches." (Reinfeldt et al. 2015) More: Cooper et al. 2017	H
MRI artifacts	The implanted magnet of passive transcutaneous boneconduction devices is causing artefacts on MR images. (HEARRING consensus)	H
Skin necrosis	"The minor complication rate was 13.1%. In total, the complication rate for pTCBIs was 18.3%." (Cooper et al. 2017) "The skin around the abutment needs life-long daily care, and skin complications, such as skin irritation, skin infections, and skin growing over the abutment, occur." (Reinfeldt et al. 2015)	H
Poor cosmetics	Cooper et al. 2017	H X	Suggestion to delete / subjective opinion
Large incision	"The standard surgical technique for BAHA Attract is a multi-tools time-consuming process, which requires a large cutaneous incision." (Dolhen et al. 2020)	A

Comment:

Title

BONE CONDUCTION | Percutaneous

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
Easy simple surgery	"Although the overall complication rate for BAHAs is low and the required surgery is simple, the percutaneous approach may produce minor or major complications at the interface between the titanium screw and the surrounding skin." (Gerdes et al. 2016)	H
MRI compatible	"This pilot study indicates that the present BCI may withstand 1.5 Tesla MRI with only minor effects on its performance." (Jansson et al. 2015)	H
Good audiological gain	"These devices use an osseointegrated percutaneous titanium implant to transmit sound vibrations generated by an external audio processor to the temporal bone. These devices have been well studied and have excellent audiometric results." (Cooper et al. 2017) More: Janssen et al. 2012, Goycoolea et al. 2020, Gerdes et al. 2016	H

Comment:

Drawbacks

Drawbacks

Statement	Literature	Notes
Skin complication - permanent wound care required	"Multiple studies reported postoperative skin irritations and wound infections due to the permanent skin penetration of the fixation screw." (Schilde et al. 2017) "Surgically implanted bone anchored hearing aids that are directly anchored in the temporal bone circumvent these problems, but their use is associated with an increased risk of dermatological complications due to the penetration of the skin surface necessitating constant wound care." (Skarzynski et al. 2019) "Approximately 20% of the patients suffered from skin irritations and in 5% of the cases surgical interventions were necessary to rehabilitate the skin complications." (de Wolf Maarten et al. 2008) More: Shirazi et al. 2006, Wazen et al. 2008, Hobson et al. 2010, Gluth et al. 2010, Shapiro et al. 2018	H
Overall complication rate	In this study with over 600 patients the Baha complication rate was 23,9%. (indirect citation / Hobson et al. 2010) More: Schwab et al. 2019	H
Maitanance and repair costs	n/a	H X	Suggestion to delete / product specific
Osseointegration complication	"Osseointegrated implants require frequent maintenance care from the surgeon. Complication rates are higher for children with a diagnosis of a craniofacial syndrome, and the risk of a complication increases significantly over a prolonged period of time." (Ida et al. 2011) Reyes et al. found that 30% of the patients with either an osseointegrated percutaneous bone conduction hearing implant or auricular prosthesis had at least one adverse skin reaction (indirect citation / Reyes et al. 2000) More: Wazen et al. 2008	H
Feedback noise	"Main acoustic shortcomings included wind noise, speech in noise, and feedback." (Medical Advisory Secretariat 2002)	H

Comment:

Title

SSD | No treatment

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
No risk	n/a	H X	Suggestion to delete / traffic, balance issues, …
No stigma	"No treatment does avoid the risk of invasive surgery and some of the burden associated with comfort of some of the other treatment options, but does not provide any form of hearing rehabilitation." (Wie et al. 2010) More: Cho et al. 2020, Lucas et al. 2017	H
No cost/no immediate costs for the health care system	Via no application of any treatment option, patients do not consume any resources of the health care system at the moment. (HEARRING consensus)	H X	Rewording to "no immediate costs for the health care system" suggested
No restrictions	n/a	H X	Suggestion to delete / all the disadvantages of SSD

Comment:

Untitled 1

Drawbacks

Statement	Literature	Notes
No hearing improvement	"In individuals with permanent unilateral deafness, 93% reported that hearing loss affected communication. Eighty-seven percent reported problems with speech perception in noisy settings. Other consequences were feelings of exclusion, reduced well-being, and extensive use of speech perception strategies."(Wie et al. 2010) More: Firszt et al. 2017, Anne et al. 2017, Carlsson et al. 2011, Dornhoffer et al. 2016, et al. Purcell et al. 2016	H
Societal consequences - delayed development, poorer academic performance, lower job perf.	Classroom environment, which typically has a background noise level of 50 to 70 dB SPL, presents a challenge for those with SSD because with only one ear receiving auditory information, the auditory centers in the brain are deprived of the complete acoustic picture which would be provided by two ears (indirect citation / Wie et al. 2010)) Dornhoffer et al. (2016) showed that Children with single-sided deafness are at higher risk of delayed speech-language development (trouble producing sounds and/or understanding speech, poor academic performance, behavioural problems, and decreased quality of life than their normal-hearing peers.(indirect citation / Dornhoffer et al. 2016)) Somewhat similarly, a large case series from Omaha, Nebraska, of 324 children and adolescents with UHL found 31% of the children to have scholastic or behavioral problems in school. Evidence suggests that educational disparities continue into adolescence. (indirect citation / Purcell et al. 2015) More: Anne et al. 2017, Lieu et al. 2010, 2012, Bovo et al. 1988, Carlsson et al. 2011, Bishop et al. 2010, Ehrmann-Müller et al. 2020	A
Personal consequences - social isolation, headaches, fatique, tinnitus, fear of loosing good ear	The feeling of exclusion in communication situations with multiple speakers was a common experience, to the extent that some individuals would avoid social interaction. (indirect citation / Wie et al. 2010) Even in quiet environments, 83% felt it was still important to sit in a strategic position for the sound source. (indicrect citation / Wie et al. 2010) More: Anne et al. 2017, Lieu et al. 2010, 2012, Bovo et al. 1988, Carlsson et al. 2011, Bishop et al. 2010	A
Audiological consequences - difficulties hearing in noise, difficulties localisation	With just one normal hearing ear it sounds to the individual with SSD as though all sounds originate from the side of the good ear, even if the sound actually originated from the contralateral side (indirect citation / Wie et al. 2010) Understanding speech in noise or more challenging listening environments presents a significant challenge (indirect citaion / Wie et al. 2010.) More: Anne et al. 2017, Lieu et al. 2010, 2012, Bovo et al. 1988, Carlsson et al. 2011, Bishop et al. 2010	A

Comment:

Title

SSD | CROS hearing aid

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
Non invasive	"… CROS hearing aids offer a nonsurgical option to compensate for some of the deficits that occur when a listener is limited to a single ear. " (Snapp 2019) "The CROS system transmit sound signals from the impaired ear via a wire (or wireless) to a microphone in the better ear. Compared to CI, it is relatively inexpensive and non-invasive, but wearing a device on both sides can be inconvenient." (Cho et al. 2020) More: Ryu et al. 2014	H
Trial period possible	As CROS hearing aids are a non-invasive solution, patients can easily try the device according to their needs. (HEARRING consensus)	H
No artefact with MRI	As CROS hearing aids are a non-invasive solution, only the removal of the device is necessary to undergo MRI. (HEARRING consensus)	H
Can add gain to the good ear	"CROS hearing aids transmits the sound from a microphone placed at the impaired ear to an amplifier and a receiver positioned at the normal ear. As there is no need for surgery, it is easily available in USNHL patients." (Ryu et al. 2014) More: Cho et al. 2020, Mertens et al. 2018	H
Benefit for speech in noise	"The primary benefit associated with the use of implantable or non-surgical cross-hearing devices is enhanced signal-to-noise ratio (SNR) in noisy and reverberant spaces, especially when the primary speech signal and background noise are spatially separated" (Ryu et al. 2014) More: Wazen et al. 2003, Hol et al. 2004, Niparko et al. 2003, Finbow et al. 2015	A
Subjective speech communication	" (…) noninvasive CROS solutions can successfully rehabilitate certain monaural listening deficits, provide improved hearing outcomes, and expand the reach of treatment in this population." (Snapp et al. 2017) More: Peters et al. 2015	A
Skin intact	To benefit from CROS hearing aids, no surgery is necessary and therefor in all situations the skin stays intact. (HEARRING consensus) More: Bishop et al. 2009	A
Alleviation of the head shadow	"As a result, lifting the negative effect of head shadow on monaural hearing as well as providing sound awareness of both sides of the head can be possible, and consequently enhancing spatial balance and speech perception ability in noise." (Ryu et al. 2014)	A

Image: https://www.widex.ch/de-ch/hearing-aids/hearing-aid-accessories/widex-cros

Comment:

Untitled 2

Drawbacks

Statement	Literature	Notes
No binaural hearing	"(…) rerouting of signal does not result in restoration of binaural function, but serves to reduce the head-shadow effect." (Snapp et al. 2017) More: Bishop et al. 2010	H
No localization	"There was no improvement in localization ability in the aided condition and no significant difference in performance with CROS versus bone-anchored implants (BAI)." (Snapp et al. 2017) More: Cho et al. 2020, Augustine et al. 2012, Niparko et al. 2003, Hol et al. 2004, 2010, Peters et al. 2015	H
No benefit for tinnitus	Could you please recommend a paper here including the the topics SSD, CROS, tinnitus supression?	H
Rarely effective in all situations	"We determined that the negative impact of listening to speech in the milieu of noise was individually variable." (Cho et al. 2020) More: Welsh et al. 2004	H
Occlusion of the good ear	"Most patients found it unpleasant to have an earmold with partial occlusion in their hearing ear or to have an abutment in their skull that required diligent care." (Müller-Isberner et al. 2015) More: Lin 2006, Lindsey et al. 2009, Ryu et al. 2014	H
Noise on HA side can decrease benefit in good ear	The rerouting of signal might lead to additional distortion on the good hearing side when background noise is transmitted to the good ear. (HEARRING consensus) More: Peters et al. 2015	H
Poor SNR	"(…) as a result of the squelch effect (NHSHLN), the SRT (−6.25 dB) was statistically significantly higher (P < .01)" (Cho et al. 2020) "Regarding the head-shadow effect, CROS transmitted the target speech from the poor hearing side to the opposite side most effectively and showed statistical significance (P < .05) with the only negative SRT (−1.55 dB)." (Cho et al. 2020) More: Peters et al. 2014, 2015	A
No benefit on QOL	"Based on moderate level of evidence studies, neither BCD nor CROSS provides benefit regarding speech perception in noise and sound localization. Quality of life did not improve"(Peters et al. 2014)	A

Comment:

Title

SSD | Bone conduction device

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
Effective against headshaddow (up to conversational level)	"Speech audiometry showed a significant head shadow benefit with both implantable bone conduction devices." (Desmet et al. 2012) Van der Heyning 2017, Hol et al. 2010, Mertens et al. 2018, Desmet et al. 2012	H
Easy testing	"A trial with a BCD can be performed by attaching the BCD to a tight headband." (Peters et al. 2015) More: Spielman 2018, Mertens et al. 2017, Desmet et al. 2012, Hol et al. 2010, Kompis et al. 2011, Wendrich 2017, Rainsbury et al. 2016	H
No need to close the good ear / good ear stays free	"A CROS conducts signals from the hearing field of the poor ear via a wire (or FM/Bluetooth) to a microphone in the ear canal of the better ear. Although the ear canal of the better ear is now partly obstructed, sound awareness is restored. A BCD transfers signals from the hearing field of the poor side to the better hearing ear by vibration of the bone of the skull." (Peters et al. 2014) More: Hol et al. 2005	H
Chepaer than CI	"(…) it is estimated that the global cost of cochlear implantation is approximately EUR 30,000 while rehabilitation by CROS hearing aids or BAHA may cost EUR 2000 to EUR 3800." (Marx et al. 2019) Ontario Health Technology Assesment 2020	H
No side effects / no rehab	Marx et al. 2020	H X	Suggestion to delete it / not specific for this concept?
Better speech understanding	"Bone-anchored hearing aid systems transmit sound to the better side by bone conduction (BC). (…) Several studies have shown significant speech understanding improvement and improvement of quality of life for SSD." (Laske et al. 2015) More: Mertens et al. 2018, Snapp et al. 2019, Salcher et al. 2017, Van der Heyning et al. 2017, Yuen et al. 2009, Lin et al. 2006, Maier et al. 2013, Gerdes et al. 2014	A
Better WRS	"The median WRS at 65 dB SPL increased significantly from 0 to 80% (mean: 8% versus 84%)." (Salcher et al. 2017) More: Siegert et al. 2013	A
Subjective benefit	"Bone-anchored hearing aid systems transmit sound to the better side by bone conduction (BC). (…) Several studies have shown significant speech understanding improvement and improvement of quality of life for SSD." (Laske et al. 2015) More: Tavora-Vieira et al. 2013, Van der Heyning et al. 2017, Boleas-Aguirre et al. 2012, Desmet et al. 2014, Oeding et al. 2013, Peters et al. 2015, Gerdes et al. 2014, Jung et al. 2019, Salcher et al. 2019	A
Improvement of schoolastic performance	In children, a fairly rapid hearing rehabilitation period is important since they may, after a fairly short time, lag behind in school or in development since they frequently cannot follow classroom activities or social interactions (indirect citation / Tomlin et al. 2014) More: Mertens et al. 2018, Urik et al. 2019, Bovo et al. 1988	A

Comment:

Untitled 3

Drawbacks

Statement	Literature	Notes
No directional hearing / sound localisation / no binaural hearing / lateralisation possible	"Theoretically, CROS and BCD can alleviate the head shadow effect and thus improve speech perception in noise and sound localization, and they also may have a beneficial influence on quality of life. However, both modalities do not restore binaural hearing." (Peters et al. 2014) More: Agterberg et al. 2019, Battista et al. 2013, Hol et al. 2005, 2010, Hobson et al. 2010	H
No stereophonic	Peters et al. 2014	H
Possible failures for implant	During the counselling process it should be mentioned that every technical device/implant can fail and lead to further surgeries, although studies show that the reliability rates are extremely high.	H X	Suggestion to delete it / with all devices given?
Percutaneous skin infections	"Multiple studies reported postoperative skin irritations and wound infections due to the permanent skin penetration of the fixation screw." (Schilde et al. 2017) "When increased pressure on skin is used to improve the effect, the skin may be irritated, red and itchy, leading to significant discomfort. Skin necrosis was also reported." (Urik et al. 2019) More: Schwab et al. 2019, Shirazi et al. 2006, Wazen et al. 2008, Hobson et al. 2010, Gluth et al. 2010	H
Aesthetics for percutaneous	"The percutaneous abutment connection system is disadvantageous in terms of aesthetics, and regular hygiene and care of the surgical site are necessary." (Cho et al. 2020) More: Cooper et al. 2017, Lindsey 2009	H X	Suggestion to delete it / subjective
Doesn't help for tinnitus	"However, for people with severe to profound sensorineural hearing loss, hearing aids and other forms of sound enrichment are not useful for tinnitus treatment. In recent years, patients with severe to profound hearing loss have sought cochlear implantation as a means of tinnitus relief when other treatments were found to be ineffective." (Holder et al. 2017) More: Holgers et al. 2002	H
Not a permanent solution	In cases of progressive hearing loss, the indication criteria should be studied well before choosing a device to avoid limited gain in the future. (HEARRING consensus)	H X	Suggestion to delete it / why not?
Difficulties when noise come from the side of the deaf ear / not benefitial in all situations	Niparko et al. 2003, Wazen et al. 2003, Yuen et al. 2009, Lin et al. 2006, Bovo et al. 2011	A
Percutaneous - rate of revision surgery	Complications with a percutaneous device that necessitate revision surgery are also high - rates vary between 5,8% and 12,1% of cases depending on study (indirect citation / Schwab et al. 2019) More: Wazen et al. 2008, Hobson et al. 2010	A
Percutaneous - overall complication rate	Baha complication rate 23,9% (study includes n=600) (indirect citation / Hobson et al. 2010) More: Schwab et al. 2019, Peters et al. 2014	A

Comment:

Title

SSD | Cochlear implant

Notes:

H - Proposed by HEARRING

A - To be added?

X - To be modified or removed?

Benefits

Statement	Literature	Notes
Restoring hearing in deaf ear	"Results of the present study showed that adults with acquired moderate-to-profound UHL benefit from receiving a CI, with improved ability to localize sound on the horizontal plane and modest benefits for masked sentence recognition in a subset of conditions." (Buss et al. 2018) "A CI is the only device that can restore auditory input in the deafened ear and provide the user with access to the binaural hearing system." (Kurz et al. 2020) More: Tavora-Vieira et al. 2013, Lorens et al. 2019, Finke et al. 2014, Peters et al. 2018, Arndt et al. 2011, Firszt et al. 2012, Blasco et al. 2014	H
Binaural hearing	"Patients with a postlingual onset of a profound hearing loss in one ear and normal hearing or only a moderate loss in the other ear are able to make the effective use of a CI in the profound-loss ear in conjunction with acoustic stimulation of the other ear." (Lorens et al. 2019) More: Mertens et al. 2017, Buss et al. 2018, Tavora-Vieira et al. 2019, 2015, Erbele et al. 2015	H
Decreased head shadow (in next point)	"CIs provide listeners with unilateral deafness important benefits for speech perception in complex spatial environments, including a larger head-shadow benefit when speech and noise originate on opposite sides of the head." (Bernstein et al. 2017) More: Vlastarakos et al. 2014, Kitoh et al. 2016, Kurz et al. 2020	H X	Suggestion to merge with the next point
Improved SNR - significant reduction of head shadow, slight improvement in summation & squelch	"To understand the impact of SSD, it is imperative to review the importance of binaural advantages such as the head shadow effect, localization, binaural summation, and the binaural squelch effect. The loss of these advantages due to SSD may be detrimental in many listening situations" (McKay 2010) Tavora-Vieira et al. (2013) observed significant improvement in speech in noise scores for 3 challenging spatial configurations (indirect citation / Tavora-Vieira et al. 2013) More: Tavora-Vieira et al. 2019, Buss et al. 2018, Mertens et al. 2017, Arndt et al. 2017, Plontke et a. 2013, Hansen et al. 2013, Mlynski et al. 2012, Lorens et al. 2019	H X	Suggestion to merge with the previous point
Better localization and directionality	Literature shows a statistically significant improvement of localisation abilities after CI implantation, but the duration of deafness influences the results (consensus statement) Buss et al. 2018, Mertens et al. 2016, Tavora-Vieira et al. 2016, Arndt et al. 2017, Lorens et al. 2019, Blasco et al. 2014, Erbele et al. 2015, Großmann et al. 2016, Kurz et al. 2020	H
Increased confidence in social situations	"When analyzing the SSQ results with a one-way repeated measures ANOVA, it is shown that, in daily living, the CI adds significantly to the acoustic hearing in both groups when it comes to speech understanding and quality of sound." (Vermeire et al. 2009) More: Arndt et al. 2011, Kleine Punte et al. 2011, …	H
Decreased fatique	Bess et al. (2014) showed how exhausting listening with SSD can be and the beneftit a CI can bring. (indirect citation / Bess et al. 2014)	H
Increased listening and language acquistion	McKay (2010) states, that getting access to the advantages of binaural hearing, leads to increased listening and language acquistion. (indirect citation / McKay 2010) Dirks et al. 2019, Tavora-Vieira et al. 2015, Buss et al. 2018	H
Increased scholastic performance	During the period of development, binaural hearing is even more important in young children than it is in adulthood. As shown in longitudinal studies, pediatric UHL can lead to significant psychosocial difficulties and school problems (…) (indirect citation / Lieu et al. 2012) More: Bess et al. 2014	H
Increased cost benefit	Marx et al. 2019, Muigg 2020, Ontario Health technology assesment 2020	H X	Suggestion to delete / country specific - reimbursment
Increased quality of life and opportunities for individual recipients	"Furthermore, cochlear implantation in patients with SSD and additional tinnitus was successful for tinnitus reduction and able to improve quality of life." (Prejban et al. 2018) More: Vermeire et al. 2009; Arndt et al. 2011; Kleine Punte et al. 2011; Pok et al. 2011, Dillon et al. 2017, Mertens et al. 2017, Tavora-Vieira et al. 2019,	H
Increased music appreciation	"Music enjoyment from electric stimulation is extremely poor relative to a readily interpretable NH baseline for CI-SSD listeners. However, the combination of this unenjoyable signal presented through a CI and an unmodified acoustic signal presented to a NH (or near-NH) contralateral ear results in enhanced music enjoyment with respect to the acoustic signal alone." (Landsberger et al. 2019) "For all objective tests of music discrimination and speech perception in noise, there were no statistically significant differences between MED-EL and Cochlear CI systems. Subjectively, four subjects thought their MED-EL device was better than their Cochlear device for music appreciation. Four thought that music sounded more natural, less tinny and more reverberant with their MED-EL CI than with their Cochlear CI." (Harris et al. 2011) More: Brockmeier et al. 2013	H
Tinnitus reduction	"Electrical Stimulation via a CI resulted in a significant reduction in tinnitus loudness (…)." (Van der Heyning et al. 2008) More: Peter et al. 2019 (systematic review), Häußler et al. 2019, Liu et al. 2018, Dillon et al. 2017, Todd et al. 2017, Tavora-Vieira 2015, Mertens et al. 2016	H
MRI conditionality	"Patients undergoing 1.5 T MRIs with devices including a diametrically bipolar magnet or a rigid implant screw fixation, experienced no pain, even without headbands." (Todt et al. 2018) "Intraindividual artifact size differences between the three magnets and are smaller than interindividual maximum artifact size differences. 3 T MRI scans, in comparison to 1.5 T MRI scans, show a difference between soft artifact areas. Conclusion: We observed no major difference between maximum implant magnet artifact sizes of the three implant magnet types." (Todt et al. 2020) More: Wimmer 2019, Bawazeer 2019	A
Also elderlys QOL benefits	Cloutier et al. (2014) showed great quality of live benefits and significant improvement in audiologic performance as seen in speech recognition scores (indirect citation / Cloutier et al. 2014) More: Carlson et al. 2010	A

Image: https://www.facebook.com/pg/neciconvention/posts/

Comment:

Untitled 4

Drawbacks

Statement	Literature	Notes
Acceptance of CI hearing	"The rapid increase of hearing-related QoL after 3-6 months ... indicates that our patients had little problems with adapting to the new hearing sensation provided by the CI." (Muigg et al. 2019) Tavora-Vieira and Rajan (2015) presented a 6.8-year-old child who did not derive any benefit of speech comprehension in noise by the CI in the different test conditions. (indirect citation / Tavora-Vieira et al. 2015)	H
CI requires life long aftercare	"After implantation, the surgeon is responsible to organize and perform a life-long follow-up. It refers to the technical check-up as well as the settings of the implants. Furthermore, regular updates of the software and hardware are necessary since they make progress of the implant technology useable for the patients." (Lenarz 2018)	H
Intensive counselling and follow up	"However, CI surgery is expensive and duration of SSD affects the outcome." (Cho et al. 2020) More:Vlastarakos et al. 2014	H
Need for rehab	"Nevertheless, several studies have defended the importance of intensive auditory training in order for all CI users with SSD, regardless of age, to achieve optimal outcomes." (Tavora-Vieira et al. 2019) More: Vlastarakos et al. 2014, Lazard et al. 2012	H
Not reaching expected benefit	Intensive counselling about certain topics (duration of deafness, motivation for rehab, …) is necessary to give realistic expectations about the benefit after implantation.	H X

Comment:

1. Would this tool be a useful item for your own counselling process?
- Yes
- Maybe
- No
2. Is the tool user-friendly and straightforward?
- Yes
- Yes and no
- No
3. As this tool is representing a consensus of the HEARRING group, we would like to ask you if it should be published?
- Yes
- No
3a. If yes, where?
4. General input about the tool

HCT Survey

HEARRING Counselling Tool (HCT) Survey

Step 1 of 10 - Introduction